C.R. BARD, INC. (BASD) -3006260740 POWERPORT DUO M.R.I. IMPLANTABLE PORT, CHRONOFLEX DUAL-LUMEN, 9.5F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1829500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Sepsis (2067); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)
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Event Date 02/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.Expiry date: 07/2019.Device not returned.
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Event Description
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It was reported through a post-market clinical follow-up survey of post power port placement, there were one occurrence of sepsis, heart failure and respiratory failure.The current status of the patient is not provided.
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Search Alerts/Recalls
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