C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 9808560 |
Device Problems
Degraded (1153); Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2023 |
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 return of the sample is pending.The investigation of the reported event is currently underway.H10:d4 (expiry date: 10/2021) 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.
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Event Description
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It was reported that three years ten months twenty days post port placement procedure via the right internal jugular vein for chemotherapy, a contrast ct examination was performed through the port, the patient allegedly complained of neck pain and leakage of contrast medium allegedly occurred in a subcutaneous tunnel.Reportedly, the port system was removed.There was no reported patient injury.
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Event Description
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It was reported that three years, ten months and twenty days post port placement via the right internal jugular vein for chemotherapy, a contrast computed tomography examination was performed through the port, the patient allegedly complained of neck pain and leakage of contrast medium allegedly occurred in a subcutaneous tunnel.Reportedly, the port system was removed.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 powerport isp mri implantable port attached to a groshong catheter was received for evaluation.Visual, microscopic, tactile and functional evaluations were performed.Multiple breaks were noted to the catheter proximal to the cath-lock.A partial compound circumferential break was noted from the distal end of the cath-lock.The edges of the partial compound break were noted to be uneven and the surface was observed to be granular and degraded.Upon infusion, water was noted exiting the partial compound break.Therefore the investigation is confirmed for the reported leak and the identified fracture and degraded issues.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 (expiry date: 10/2021), g3, h6 (device).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.
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Search Alerts/Recalls
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