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
Bacterial Infection (1735); Septic Shock (2068)
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Event Date 06/04/2022 |
Event Type
Injury
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Event Description
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It was reported through the litigation process that four years, eight months, and twenty-one days post a port placement via the right internal jugular vein, the patient was allegedly diagnosed with septic shock.It was further reported that the patient allegedly developed with methicillin-resistant staphylococcus aureus bacterial infection as a result of the defective infected port.Reportedly, the plaintiff underwent removal of the infected port.The current status of the patient is unknown.
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not 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.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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