Catalog Number 393224 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problems
Foreign Body In Patient (2687); Insufficient Information (4580)
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Event Date 10/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that venflon pro safety 20ga 1.1mm od 32mm l catheter broke.The following information was provided by the initial reporter: problems with iv, burr and elevations in cannula (catheter).Pieces come loose in the blood vessel, this is very dangerous.
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Event Description
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It was reported that venflon pro safety 20ga 1.1mm od 32mm l catheter broke.The following information was provided by the initial reporter: problems with iv, burr and elevations in cannula (catheter).Pieces come loose in the blood vessel, this is very dangerous.
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Manufacturer Narrative
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H6: investigation: two photos, nine representative samples, and five used samples were received by our quality team for evaluation.The representative samples were subjected to visual inspection and no abnormalities were observed.One used 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.
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Search Alerts/Recalls
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