C.R. BARD, INC. (BASD) -3006260740 POWERPORT MRI, 9.6 FR. SILICONE, INTER. KIT W/SUTURE PLUG, S/L; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1859600 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bacterial Infection (1735)
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Event Date 07/17/2020 |
Event Type
Injury
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Event Description
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It was reported that one year, nine months and fifteen days post a port placement, the patient was allegedly diagnosed with gram-positive bacteremia.It was further reported that the patient was allegedly diagnosed with blood stream infection and the culture test resulted positive for gram-positive bacteria.Reportedly, the device was removed.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4: (expiry date: 06/2021).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.
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Search Alerts/Recalls
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