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It was reported that 2 bd venflon¿ pro safety peripheral safety iv catheters from lot 1175161, and 1 catheter from lot 1140550 had visible silicone on their cannulas.
The following information was provided by the initial reporter: "customer reported a bulge on cannula.
" via bd investigation: "four of the ten samples were observed with a gel-like substance on the catheter which is similar to the reported defect.
" "based results, the gel-like substances are similar and found to be silicone compound from catheter lube.
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Date of event: unknown.
There were multiple lot numbers reported to be involved.
The information for each lot number is as follows: medical device lot #: 1175161; medical device expiration date: 2024-06-30; device manufacture date: 2021-08-04.
Medical device lot #: 1140550; medical device expiration date: 2024-05-31; device manufacture date: 2021-06-25.
Date received by manufacturer: bd was initially made aware of this complaint on 2021-09-30.
At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.
Additional information was later received on 2021-11-18 that changed the reportability determination.
Based on the additional information received, this complaint is now considered to be an mdr reportable incident.
Investigation summary: three photos and ten representative samples were received by our quality team for evaluation.
From the photos, an exposed needle with an unknown substance on the catheter was observed.
Visual inspection was performed on the returned samples.
Four of the ten samples were observed with a gel-like substance on the catheter which is similar to the reported defect.
The representative sample and catheter lube from the machine was sent for fourier transform infrared spectroscopy (ftir) analysis.
Based results, the gel-like substances are similar and found to be silicone compound from catheter lube.
A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.
The manufacturing process was reviewed.
In the catheter lubrication station, the assembled product would be dipped into high viscosity silicone lube.
Excess lube on the catheter surface would then be removed at the vacuum station.
The probable root cause for the reported condition of this complaint could be due to accumulation of catheter lube around the vacuum station holder.
The accumulated catheter lube could have been in contact with the surface of the product catheter during the vacuum process step to remove excess catheter lube.
This can cause residue of an accumulated catheter lube to be attached to the product catheter surface resulting in the gel-like substance on the catheter surface.
The other probable cause could be due to the vacuum station with clogged with excess lube and hence unable to effectively removed the excess lube from the product catheter after lubrication.
Communication with all venflon pm associates to perform proper cleaning for the vacuum station and cleaning of the vacuum station holder will be included in the quarterly preventative maintenance.
This incident has been added to our database of reported incidents.
Our business team regularly reviews the collected data for identification of emerging trends.
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