C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASULAR
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Model Number 5618000 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records 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: 03/2023.
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Event Description
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It was reported that one week post port placement, the port catheter allegedly occluded.There was no reported patient injury.
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Search Alerts/Recalls
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