C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 9808560 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that sometimes a post port placement procedure, the catheter was allegedly broken.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 sometime post a port placement, the catheter was allegedly found to be broken.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A complete circumferential break was noted on the distal end of the attached catheter and on the proximal end of the distal catheter segment.The edges of the breaks on the distal end of the attached catheter were noted to be jagged and the surface was noted to be granular.A split was noted from the proximal end of the distal catheter segment.Therefore, the investigation is confirmed for the reported fracture and the identified material separation issues.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.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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Search Alerts/Recalls
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