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 Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2024 |
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 sample was returned to the manufacturer for inspection/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 one year, four months and thirteen days post a port placement, the catheter was allegedly damaged.It was further reported that there are two damaged areas on the catheter.Reportedly the patient had discomfort and pain and the catheter was removed.There was no reported patient injury.
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Event Description
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It was reported that one year, four months and thirteen days post a port placement, the catheter was allegedly damaged.It was further reported that there are two damaged areas on the catheter.Reportedly the patient had discomfort and pain and the catheter was removed.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.Small splits were noted on the proximal end of the attached catheter.One partial compound break was noted from the distal end of the cath-lock on the attached catheter.The edges of the partial circumferential break on the attached catheter were noted to be uneven and the surface was noted to be round and smooth on both regions.Therefore, the investigation is confirmed for the reported catheter damage and identified fracture issue as the more specific damage such as partial break and splits were noted on the catheter.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.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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Search Alerts/Recalls
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