C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM LUBRI-SIL® IC COMPLETE CARE®
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Catalog Number A300416A |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that foley tray was missing the 10ml saline syringe.No product was saved as staff pulled missing syringe separately and used this tray.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that foley tray was missing the 10ml saline syringe.No product was saved as staff pulled missing syringe separately and used this tray.Per sample received on (b)(6) 2023, it was noted that the balloon dilation catheter was returned for evaluation.Per sample received on (b)(6) 2023, it was noted that the eagle inflation device was returned for evaluation.
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Manufacturer Narrative
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The reported event is inconclusive as the reported sample was not returned for this evaluation.During visual evaluation, a box was received from the customer, but the product return (balloon dilation catheter & eagle inflation device) does not match the product in this record.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be operator error.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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