C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8 FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8808560 |
Device Problems
Deformation Due to Compressive Stress (2889); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately two months post port placement, sutures were allegedly not intact.It was further reported that the catheter coiled was out of vein.Furthermore, sutures allegedly dislodged and the chamber flapped.Reportedly, the device was removed.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 not been returned to the manufacturer for evaluation.However, a photo and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2024) 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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Manufacturer Narrative
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H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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 and a video were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2024).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.H3 other text : device not returned.
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Event Description
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It was reported that approximately two months post port placement, sutures were allegedly not intact.It was further reported that the catheter coiled was out of vein.Furthermore, port sutures allegedly dislodged and the chamber flapped.Reportedly, the device was removed.The current status of the patient was unknown.
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Event Description
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It was reported that approximately two months post port placement, sutures were allegedly not intact.It was further reported that the catheter coiled was out of vein.Furthermore, port sutures allegedly dislodged and the chamber flapped.Reportedly, the device was removed.The current status of the patient was unknown.
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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 sample was not returned for evaluation, one electronic photo and one video were provided for review.The provided video and photo show a physician holding a port attached with catheter which was removed from patient body and the catheter was noted to be circular position.No other anomalies were noted.However, the investigation is inconclusive for the reported issues as the exact circumstances at the time of the reported event cannot be verified from the provided photo and video.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: 05/2024).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.H3 other text : device not returned.
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Search Alerts/Recalls
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