C.R. BARD, INC. (BASD) -3006260740 POWERPORT TI L/P 6 CF INT WOSP ATT SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8716001 |
Device Problems
Device Damaged Prior to Use (2284); Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2024 |
Event Type
malfunction
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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 was not returned to the manufacturer for inspection/evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2025).H11: 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 prior to a port placement procedure, the catheter was allegedly distorted in multiple places.The procedure was completed using another device.There was no patient contact.
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Event Description
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It was reported that prior to port placement procedure, the catheter was allegedly distorted in multiple places.The procedure was completed using another device.There was no patient contact.
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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 physical device is not returned for evaluation.However, one electronic photo was provided and reviewed.Multiple kinks were noted throughout the catheter tubing.No other visual anomalies were noted.Therefore, the investigation is confirmed for the reported deformation due to compressive stress.However, the investigation is inconclusive for the reported device damaged prior to use issue as the exact circumstance at the time of the event reported event was unknown.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 04/2025), g3, h6 (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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Search Alerts/Recalls
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