C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806061 |
Device Problems
Device Damaged Prior to Use (2284); Material Deformation (2976); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that prior to the port placement procedure, the tip of the avulsable sheath with the dilator was allegedly found to be damaged before catheterization.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4: (expiry date: 01/2025).H11: section a: through f: the information provided by bd represents all of 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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Manufacturer Narrative
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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 sample was not returned for evaluation.Three electronic photos were provided for review.The photo shows the dilator loaded in the sheath and the tip of the dilator was noted to be deformed.Therefore, the investigation is confirmed for the reported material integrity and identified material deformation issue.However, the investigation is inconclusive for the reported device damaged prior to use issue as the exact circumstances at the time of reported event was unknown.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 01/2025), g3, h6 (device, method) h11: h6 (result, conclusion) 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 prior to the port placement procedure, the tip of the avulsable sheath with the dilator was allegedly found to be damaged before catheterization.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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