C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1806050J |
Device Problems
Stretched (1601); Failure to Advance (2524); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/15/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure, the guidewire was allegedly felt to be caught during advancing.The procedure was completed using another device.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 straight-tip guidewire loaded onto a packaging hoop was returned for evaluation.Visual and dimensional evaluations were performed on the returned device.The proximal end of the guidewire was noted to be uncoiled.Therefore, the investigation is confirmed for the identified stretched issue.However, the investigation is inconclusive for the reported guidewire stuck and advancement difficulty issues as the exact circumstance at the time of the event reported cannot be reproduced under laboratory condition.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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