C.R. BARD, INC. (BASD) -3006260740 LOW ARTIFACT POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNK LOW ARTIFACT POWER PORT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 09/05/2018 |
Event Type
Injury
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Event Description
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It was reported through the litigation process that nine months and twenty-two days post a port placement via the right internal jugular vein, the patient allegedly experienced right chest wall swelling, tenderness, erythema, and purulent drainage at the port site.It was further reported that blood cultures were drawn and were resulted positive.Reportedly, the infected 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 physical device was not returned for evaluation.No medical record were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.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 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.H3 other text : device not returned.
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Search Alerts/Recalls
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