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
Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that sometime post a port placement, the catheter was allegedly seemed to be pierced.It was further reported that the catheter allegedly had a leak.Reportedly, the port 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 return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 11/2024).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: 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 powerport mri isp implantable port attached to a groshong catheter and one catheter stylet were returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.A compound break was noted from the distal end of the cath-lock.The edges of the compound break were noted to be uneven and the surface was noted to be round and smooth on both regions.Upon infusion, a leak from the compound break was observed.Therefore, the investigation is confirmed for the reported leak and the identified fracture issue.However the investigation is unconfirmed for the reported material hole issue as no evidence of hole was noted.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: b5, d4 (expiration date: 11/2024), g3, h6 (device).H11: h6 (method, result).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 twenty six days post a port placement, the catheter was allegedly seemed to be pierced.It was further reported that the catheter allegedly had a leak.Reportedly, the port was removed and replaced.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 (expiration date: 11/2024), g3, h6 (method) h11: b5, h6 (result, conclusion) 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 twenty six days post a port placement, the catheter was allegedly seemed to be pierced.It was further reported that the catheter allegedly had a leak.Reportedly, the port was removed.There was no reported patient injury.
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Search Alerts/Recalls
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