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Dear all,
Further to below:
The sponsor (Pfizer) will be issuing a strategy for supply of METRONIDAZOLE INTRAVENOUS INFUSION 500mg/100mL solution for injection bag in due course.
Regards
Glenys
Glenys Harrington
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
Dear All,
To clarify this is not a Recall it is a Product Defect Alert
The manufacturer/supplier states the following:.
………..Pfizer seeks to emphasise the need for all Healthcare Professionals involved in the handling and administration of parenteral medicines to always visually inspect product as typically specified in the relevant Product Information, including that for DBL METRONIDAZOLE IV bags, which states:
Parenteral drugs should be inspected visually for particulate matter and discolouration prior to administration, wherever solution or container permit. Do not use if the solution is cloudy or precipitated or if the seal is not intact.
In addition they recommend the following:
Manual inspection of infusion bags
As with any IV bag presentation, all DBL METRONIDAZOLE INTRAVENOUS INFUSION IV bags require a manual squeeze test immediately prior to use in order to assist in a visual check for the presence of leaks from the primary bag following removal of the secondary bag (overwrap).
I would be surprised if this squeeze test is being done routinely in clinical areas, but happy to be corrected.
I would have thought that doing a squeeze test would have been the manufacturers responsibility as part of the manufacturing process, particularly given their investigation(Product Defect Alert) has identified that this leak is the result of pre-existing damage to the polycarbonate stopper, which is supplied by a third party
Why is the product not being recalled for replacement of faulty 3rd party stoppers?
In addition if a contaminated bag(outer bag) is opened the risk of staff hand contamination with mould/other organisms has not been discussed/mentioned.
regards
Glenys
Glenys Harrington
Infection Control Consultancy (ICC)
P.O. Box 6385
Melbourne
Australia, 3004
M: +61 404816434
It seems the attachment was omitted. Trying again.
Michael Wishart, CICP-E
Infection Control Coordinator
A 627 Rode Road, Chermside QLD 4032
P (07) 3326 3068 | F (07) 3607 2226 | E michael.wishart@svha.org.au | W http://www.hsnph.org.au
cid:image001.png@01D01926.61F1C2B0P Please consider the environment before printing this email
[Posted on behalf of Donna Cameron Moderator]
Dear Infexion Connexion subscribers,
I have just seen this product recall that will be of interest to many of you.
Regards,
Donna
Donna Cameron
Infection Control Consultant
T +61 (0) 3 8344 3574 (Monday, Wednesday & Friday); +61 (0) 3 9096 5233 (Tuesday & Thursday)
donna.cameron@unimelb.edu.auMicrobiological Diagnostic Unit Public Health Laboratory
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street | Melbourne | Victoria | Australia | 3000
doherty.edu.aucid:image001.gif@01D3FD7C.B4C863C0
“Australian Society for Antimicrobials” < info@asainc.net.au>
“ASA” < info@asainc.net.au>,
06/06/2018 09:12 AM
Product Defect Alert for DBL??? METRONIDAZOLE INTRAVENOUS INFUSION 500mg/100mL solution for injection bag
PO Box 8266 Angelo Street
South Perth 6151 Western AustraliaMember Update 05 Jun 2018
Pfizer Australia has informed ASA of a Product Defect Alert for DBL METRONIDAZOLE INTRAVENOUS INFUSION 500mg/100mL solution for injection bag. See attached letter.
Please feel free to contact Wayne Lee if you wish to discuss this matter further:
Wayne Lee
Associate Medical Director
Pfizer Essential HealthAustralian Society for Antimicrobials :: https://www.asainc.net.au
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