C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1616000 |
Device Problem
Device Tipped Over (2589)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2022 |
Event Type
malfunction
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Event Description
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It was reported that sometimes post port placement procedure, the port was allegedly flipped upside down.There was no reported patient injury.
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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.
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Search Alerts/Recalls
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