C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNKNOWN POWER PORT |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
Extravasation (1842)
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Event Date 11/14/2022 |
Event Type
Injury
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Event Description
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It was reported through the litigation process that six months and twenty-five days post a port placement via the right subclavian vein, the patient allegedly developed immediate extravasation of contrast over the right subclavian vein during evaluation.It was further reported that the catheter was allegedly found to have a hole that was approximately two centimeters distal to the port.Reportedly, the defective port was removed.However, the current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive for the alleged hole in catheter and extravasation as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.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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Search Alerts/Recalls
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