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
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that sometime post port placement, leakage allegedly occurred during chemotherapy use.It was further reported that after removing the port system, a test puncture was performed to check for leakage on dry guaze, but no leakage was detected.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 not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport implantable port attached to a groshong catheter was returned for evaluation.Gross visual, microscopic, tactile and functional evaluations were performed.What appeared like a pinhole, was noted approximately 11.0cm from the distal end of the cath-lock.The port body was patent to both infusion and aspiration without issue.No leaks were observed.Therefore, the investigation is confirmed for the identified material hole issue.However, the investigation is unconfirmed for the reported fluid leak issue.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.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 sometime post a port placement, leakage allegedly occurred during chemotherapy use.It was further reported that after removing the port system, a test puncture was performed to check for leakage on dry gauze, but no leakage was detected.There was no reported patient injury.
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Search Alerts/Recalls
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