C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNKNOWN POWER PORT |
Device Problems
Fracture (1260); Difficult to Remove (1528); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 01/11/2022 |
Event Type
Injury
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Event Description
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It was reported through the litigation process that eight years, eleven months, and five days post a port placement via the right internal jugular vein, the catheter was allegedly found to be fractured and separated from the port.It was further reported that the patient was forced to undergo a second procedure to attempt to remove the retained portion of the fractured catheter.Reportedly, the fractured catheter has not been removed after an attempted but unsuccessful percutaneous removal procedure.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 is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported fracture, material separation and difficult to remove as no objective evidence was provided for review.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.H3 other text : device not returned.
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Search Alerts/Recalls
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