C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 5608062 |
Device Problem
Expulsion (2933)
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Patient Problems
Hemorrhage/Bleeding (1888); Pain (1994); Skin Erosion (2075)
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Event Date 03/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that three months nine days post port placement procedure, the patient allegedly experienced redness and pain in superior aspect of site.It was further reported that patient had bleeding and skin erosion.The port was removed and replaced due to erythema and erosion of port.The patient expired due to a vehicle accident.The relationship of the adverse event was determined to be not related to device, and not related to the replacement procedure.
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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: 01/2024) 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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