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); Stretched (1601); Unraveled Material (1664); Difficult to Advance (2920)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2023 |
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guidewire was allegedly not advancing well.It was further reported that the guidewire was allegedly cracked when it was withdrawn.There was no reported patient injury.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 provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025).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guidewire was allegedly not advancing well.It was further reported that the guidewire was allegedly cracked when it was withdrawn.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one introducer needle and one j-tip guidewire loaded to a guidewire hoop were returned for evaluation.Gross visual, microscopic visual, functional and dimensional evaluations were performed on the returned device.Uncoiling and stretched were note on portion of the j-tip guidewire.Round core wire was noted to be protruded coil of the guidewire and detached from distal end of the guidewire.Flat core wire was noted to be complete break and protruded.Therefore, the investigation confirmed for the reported fracture and identified uncoiling,d stretch, protrusion and detachment.However, the investigation is inconclusive for the reported difficult to advance issue as no objective evidence to confirm this was provided for review.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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.H10: d4 (expiration date: 09/2025).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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Search Alerts/Recalls
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