C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1608062 |
Device Problem
Expiration Date Error (2528)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2021 |
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 (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: 12/2021).
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Event Description
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It was reported that prior to a procedure, the device was allegedly found to be expired based on the mislabeled product.There was no patient contact.
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Search Alerts/Recalls
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