C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP IMPLANTABLE PORT, GROSHONG, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number CP00003 |
Device Problems
Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Naturally Worn (2988)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2024 |
Event Type
malfunction
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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 device has has been returned to the manufacturer for evaluation.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 sometimes post a port placement, the catheter allegedly fractured.Reportedly, the port was removed and replaced.There was no reported patient injury.
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Event Description
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It was reported that sometime post a port placement, the catheter allegedly fractured.Reportedly, the port was removed and replaced.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 isp implantable port, one cath-lock and one groshong catheter were returned for evaluation.Visual, microscopic, functional evaluations were performed on the returned device.A complete circumferential break was noted on the distal end of the attached catheter and proximal end of the distal catheter segment that appeared elliptical in shape.The edges of the complete circumferential breaks were noted to be jagged and the surfaces were noted to be round and smooth in one region and granular in the other region.A partial circumferential break was noted from the proximal end of the distal catheter segment.The edges of the partial circumferential break was noted to be uneven and the surface was noted to be round and smooth throughout.Therefore, the investigation is confirmed for the reported fracture and the identified material separation, naturally worn and deformation issues.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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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