C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0602680 |
Device Problems
Fracture (1260); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); 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 07/18/2023 |
Event Type
malfunction
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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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2026).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 via the subclavian vein, the guide wire allegedly failed to advance.It was further reported that upon removing the guide wire, it got stuck to the puncture needle and got disintegrated after the attempt to remove it.Reportedly, after removing both the guide wire and the puncture needle, it was identified that the guide wire was no longer in conditions to be used.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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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 (expiry date: 03/2026).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 not returned.
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Event Description
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It was reported that during a port placement procedure via the subclavian vein, the guide wire allegedly failed to advance.It was further reported that upon removing the guide wire, it got stuck to the puncture needle and got disintegrated after the attempt to remove it.Reportedly, after removing both the guide wire and the puncture needle, it was identified that the guide wire was no longer in conditions to be used.There was no reported patient injury.
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Search Alerts/Recalls
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