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
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Septic Shock (2068)
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Event Date 09/11/2019 |
Event Type
Injury
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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 physical device was not returned for evaluation.Medical records were not provided.Therefore, the investigation is inconclusive for the reported adverse events 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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Event Description
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It was reported that approximately two months post a port placement, the patient allegedly developed infection related to the port and was allegedly diagnosed with methicillin-sensitive staphylococcus aureus bacteremia and septic shock.Reportedly, the patient received treatment and the port was removed.The current status of the patient was unknown.
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Search Alerts/Recalls
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