C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1618000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Burning Sensation (2146)
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Event Date 12/01/2022 |
Event Type
Injury
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Event Description
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It was reported that sometimes post port placement procedure, the patient allegedly experienced inflammation around the port.It was further reported that patient experienced burning sensation after infusion.Reportedly, tylenol was given to treat burning sensation.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 provided, a review of the device history records was 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: 08/2023.
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Search Alerts/Recalls
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