C.R. BARD, INC. (BASD) -3006260740 BROVIAC CV CATHETER REPAIR KIT, SINGLE-LUMEN,WHITE, 4.2F; PORT AND CATHETER ACCESSORIES
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Model Number 0601610 |
Device Problems
Coagulation in Device or Device Ingredient (1096); Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/20/2023 |
Event Type
malfunction
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Event Description
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It was reported that during preparation of a catheter repairing procedure, the adhesive on the device was allegedly solid and wouldn't come out of tube.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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A voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiration date: 09/2023.Device pending return.
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Manufacturer Narrative
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H10: a voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 09/2023).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.H3 other text : device not returned.
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Event Description
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It was reported that during preparation of a catheter repairing procedure, the adhesive on the device was allegedly solid and wouldn't come out of tube.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: a voluntary recall has been initiated for catheter repair kits which are product catalog/lot number specific.Reportedly the catheter repair kits have hardened/coagulated adhesive.Hardened or coagulated adhesive has the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained; therefore, potentially prolonging surgery or necessitating exchange.To date there have been no adverse events worldwide reported related to this issue.As result of the field action, this event is being reported as a malfunction reportable event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one silicone adhesive tube were returned for evaluation.Gross visual evaluations was performed.The investigation is confirmed for the reported coagulation in device, as the tube felt stiff, not spongy.However, the investigation is inconclusive for the reported non standard device issue, as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiration date: 09/2023), g3, h2 h11: h6 (method, result) 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 during preparation of a catheter repairing procedure, the adhesive on the device was allegedly solid and wouldn't come out of tube.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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