Catalog Number NS5524 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the hakim bactiseal catheter is supposed to have holes on the side of the catheter for fluid drainage in case of clogging, and when the catheter was opened it was clear that there were no holes on the side.No patient contact/injury reported and the event led to 5 minutes surgical delay.
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Event Description
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N/a.
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Manufacturer Narrative
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The catheter was returned for evaluation.Review of the history device records for lot 5028205 conformed to the specifications when released to stock failure analysis - the catheter was visually inspected; the drainage holes and markings specified on the label are not present on the catheter.The complaint was confirmed.The review of the retains samples of product code ns5524 batch 5028205 and ns0339 batch 5028206 confirmed a mix-up between these two lots that occured during impregnation process.A corrective action is in place to treat this issue.
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Search Alerts/Recalls
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