BARD ACCESS SYSTEMS POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1618070 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Local Reaction (2035)
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Event Date 08/17/2020 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review 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: 08/2021).
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Event Description
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It was reported that sometime post port placement procedure, the patient allegedly experienced itching under the dressing.It was further reported that the hives have spread up into the patient's neck, back of the shoulder, breast and arm.The patient current status is unknown.
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Search Alerts/Recalls
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