Catalog Number 388412 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2021 |
Event Type
malfunction
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Event Description
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It was reported when using the bd insyte¿ vialon e iv catheter the catheter was damaged.The following information was provided by the initial reporter.According to the customer's report (animal clinic), "the catheter was found to be damaged before use.".
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported when using the bd insyte¿ vialon e iv catheter the catheter was damaged.The following information was provided by the initial reporter.According to the customer's report (animal clinic), "the catheter was found to be damaged before use.".
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Manufacturer Narrative
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H.6.Investigation: seven photos and one sample were received by our quality team for evaluation.The photo was subjected to visual inspection to check for catheter damage.No obvious catheter damage was observed.The sample was subjected to visual inspection to check for catheter damage.A ¿v-cut¿ was observed near the catheter tip.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 ¿v-cut¿ observed on the catheter that matches the shape of the bevel, could be caused by the needle piercing through the catheter.The assembly process was reviewed.If the needle pierced through catheter occurred in the manufacturing process, the defect would be detected and auto rejected by the 100% inline tip spear vision inspection system.Needle pierced through catheter during the needle cover removal.As the sample was returned in open packaging, the actual root cause could not be established.
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Search Alerts/Recalls
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