C.R. BARD, INC. (BASD) -3006260740 POWERPORT SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1716070J |
Device Problem
Restricted Flow rate (1248)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us, but is similar to the powerport slim implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code and 510k number for the powerport slim implantable port, chronoflex single-lumen, kit, 6f products is identified.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
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Event Description
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It was reported that approximately one year post port placement procedure, the infusion rate was allegedly low.There was no reported patient injury.
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Search Alerts/Recalls
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