C.R. BARD, INC. (BASD) -3006260740 POWERFLOW APHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number A710962 |
Device Problems
Restricted Flow rate (1248); Suction Problem (2170); Obstruction of Flow (2423); Blocked Connection (2888)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/27/2021 |
Event Type
malfunction
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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 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: 09/2019).
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Event Description
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It was reported that after port placement the device allegedly had a restriction of flow rate and difficulty in accessing the port.It was further reported that the device allegedly had obstruction of flow and suction problem.There was no reported patient injury.
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Search Alerts/Recalls
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