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); Stretched (1601); Unraveled Material (1664); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2023 |
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 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 of 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 pending return.
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Event Description
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It was reported that during a port placement procedure, the guidewire was allegedly stretched.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 introducer needle loaded to a guidewire and a guidewire hoop were returned for evaluation.Gross visual, microscopic visual, functional and dimensional evaluations were performed on the returned device.Uncoiling was noted throughout the guidewire loaded to the introducer needle.Both core wires were noted to have a complete break and protruding the uncoiled portion of the guidewire.The guidewire was noted to be stuck within the introducer needle.Therefore the investigation is confirmed for the reported stretched and identified fracture, physical resistance and unraveled issues.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.A 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.H11: section a through f - the information provided by bd represents all of 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 during a port placement procedure, the guidewire was allegedly stretched.There was no reported patient injury.
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Search Alerts/Recalls
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