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Catalog Number 5396240 |
Device Problems
Fracture (1260); Difficult to Insert (1316); Stretched (1601); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2023 |
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 provide 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.H3 other text : device pending return.
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Event Description
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It was reported that during a dialysis catheter placement procedure, there was strong resistance felt during inserting the guidewire, after puncturing the needle.It was further reported that the device allegedly broken upon removal.Reportedly, another device was used to complete the procedure.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 j-tip guidewire, one introducer needle, one guidewire hoop and one needle protector were received for evaluation.Visual and functional evaluations were performed.The proximal portion of the j-tip guidewire was noted to be uncoiled and stretched.The distal portion of the j-tip guidewire was noted to be bent.Therefore, the investigation is confirmed for the identified deformation due to compressive stress and stretched issues.However, the investigation is inconclusive for the reported physical resistance and difficult to insert issues as the exact circumstance at the time of the event reported was unknown.The investigation is also unconfirmed for the reported fracture issue as no fracture was noted.The 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 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 : see h10.
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Event Description
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It was reported that during a dialysis catheter placement procedure, there was strong resistance felt during inserting the guidewire, after puncturing the needle.It was further reported that the device was allegedly broken upon removal.Reportedly, another device was used to complete the procedure.There was no reported patient injury.
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Search Alerts/Recalls
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