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
Itching Sensation (1943); Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/01/2021 |
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 record is currently being 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: 06/2022).
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Event Description
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It was reported that four days post port placement, the patient allegedly experienced skin discoloration, itching and soreness over the port region.The patient's current status was unknown.
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Search Alerts/Recalls
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