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Recall of BD Venflon Pro safety IV cannula


4 May 2021
Becton Dickinson (BD) has identified an issue with specific lots of BD Venflon Pro Safety (VPS) Needle Protected IV Cannulae after identifying an increase in reports of leakage from the injection port.
BD has issued an updated Field Safety Notice (FSN) and is recalling all products sterilised by ethylene oxide (EtO). It does not affect products sterilised by electron beam. Check the FSN for affected product codes and details on how to identify sterilisation methods used.
Risk involved with using affected product
There is a risk of blood or fluid loss from the injection port, which can result in serious harm if undetected. ....

United Kingdom , Northern Ireland , Becton Dickinson , Pro Safety , Needle Protected , Field Safety Notice , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , பெக்டன் டிக்கின்சன் , ப்ரொ பாதுகாப்பு , புலம் பாதுகாப்பு அறிவிப்பு ,

Total parenteral (TPN) and enteral nutrition bags manufactured by Diffuplast: Sterilisation issue


Instructions for Medical Device Safety Officer/Medicines Safety Officer: Please circulate/forward to relevant departments
The manufacturer (Diffuplast) has identified a potential issue with their third-party sterilisation provider, which means that while a sterilisation process has been carried out and the devices are likely to be sterile, they have not been sterilised to the usual standard. However, the risk to patients is very low and therefore patients should continue to use their products as normal.
However, note that only the following products listed on this FSN are supplied in the UK:
Exacta Mix parenteral nutrition bags (see FSN for specific product codes and batch numbers) ....

United Kingdom , Northern Ireland , Public Health England , Chief Pharmacist , Parenteral Nutrition , Medical Device Safety , Medicines Safety Officer , Field Safety Notice , Eto Top Fill , Yellow Card , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , பொது ஆரோக்கியம் இங்கிலாந்து , தலைமை மருந்தாளர் , பெற்றோர் ஊட்டச்சத்து , மருத்துவ சாதனம் பாதுகாப்பு , புலம் பாதுகாப்பு அறிவிப்பு , மஞ்சள் அட்டை ,

National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)


Reference No: NatPSA/2021/001/MHRA
This alert is for action by: primary and secondary care, blood transfusion services, specialist outpatient settings, oncology providers, hospices, private healthcare
This is a safety critical and complex National Patient Safety Alert. Implementation should be coordinated by a senior member of staff e.g. Medical Director supported by Chief Pharmacist, Chief Nurse, Head of Infection Control and Head of Procurement/Supplies or equivalent roles.
Explanation of identified safety issue
Becton Dickinson (BD) have notified MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.
BD is recalling all affected stock of the following products ....

United Kingdom , Northern Ireland , National Patient Safety Alert , National Patient Safety , Chief Pharmacist , Chief Nurse , Infection Control , Field Safety Notice , Smartsite Needle Free , ஒன்றுபட்டது கிஂக்டம் , வடக்கு ஐயர்ல்யாஂட் , தேசிய நோயாளி பாதுகாப்பு எச்சரிக்கை , தேசிய நோயாளி பாதுகாப்பு , தலைமை மருந்தாளர் , தலைமை செவிலியர் , தொற்று கட்டுப்பாடு , புலம் பாதுகாப்பு அறிவிப்பு ,