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Model Number 5833690 |
Device Problems
Entrapment of Device (1212); Fracture (1260); Material Separation (1562); Stretched (1601); Unraveled Material (1664); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2023 |
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 device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2024).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 dialysis catheter placement procedure in the right atrium via the jugular vein, after the puncture, the guide wire allegedly met resistance while implanting and was difficult to adjust.It was further reported that when the guidewire was found difficult to adjust through the puncture needle, the whole device was removed to adjust, and it was found that the thin wire in the guide wire was allegedly fractured.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 19cm hemostar d/l catheter, one 15.0fr peel-apart sheath and vessel dilator, one 8fr & 12fr dilator, one introducer needle, one j-tip guidewire, one guidewire hoop, one tunneler with a loaded protective sheath and one end cap were returned for evaluation.Gross visual, tactile, dimensional and functional evaluations were performed.The j-tip guidewire was noted to be uncoiled in the distal portion.Both core wires were protruding the coils of the guidewire and noted to have complete breaks on the ends.In addition to the returned physical sample, one electronic photo was provided for review.The photo shows a guidewire was stretched at the distal end and both the round and flat core wires were noted to be broken and protruding.Therefore, the investigation is confirmed for the reported fracture and identified material separation, stretched and unraveled issues.However, the investigation is inconclusive for the reported difficult to advance and physical resistance issues as the exact circumstances at the time of the reported event was unknown.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 the 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: 03/2024).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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Event Description
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It was reported that during a dialysis catheter placement procedure in the right atrium via the jugular vein, after the puncture, the guide wire allegedly met resistance while implanting and was difficult to adjust.It was further reported that when the guidewire was found difficult to adjust through the puncture needle, the whole device was removed to adjust, and it was found that the thin wire in the guide wire was allegedly fractured.There was no reported patient injury.
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Search Alerts/Recalls
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