C.R. BARD, INC. (BASD) -3006260740 APHERESIS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number A710962 |
Device Problems
Difficult to Flush (1251); Suction Problem (2170); Blocked Connection (2888)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: 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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Event Description
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It was reported that during the preparation of a port placement procedure, the port was allegedly not able to be accessed using two different needles.It was further reported that on both attempts, fluid was allegedly not able to be withdrawn or flushed.There was no patient contact.
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Search Alerts/Recalls
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