C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806061 |
Device Problems
Fracture (1260); Failure to Advance (2524)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 (expiration date: 08/2024).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 port placement procedure in the right chest wall via the right internal jugular vein, when opening the package and checking the accessories and then flushing the kit, the threads were allegedly found to be broken at the catheter sheath tear handle.It was further reported that it was not possible to tighten the dilator, and was judged that the process of entering the sheath along the guidewire couldn't be completed successfully.The procedure was completed by using another device.There was no reported patient injury.
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Event Description
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It was reported that during a port placement procedure in the right chest wall via the right internal jugular vein, when opening the package and checking the accessories and then flushing the kit, the threads were allegedly found to be broken at the catheter sheath tear handle.It was further reported that it was not possible to tighten the dilator and was judged that the process of entering the sheath along the guidewire couldn't be completed successfully.The procedure was completed by using another device.There was no reported patient injury.
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Manufacturer Narrative
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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 sample was not returned for evaluation.However, one electronic photo was provided for review.There was no visible broken sheath thread was noted in photo.Therefore, the investigation is inconclusive for the reported sheath broken thread and failure to advance as no objective evidence received from provided information.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.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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Search Alerts/Recalls
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