C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1808060 |
Device Problems
Device Appears to Trigger Rejection (1524); Suction Problem (2170)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/13/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately three years post port placement procedure, the port allegedly had suction issue.The patient is being treated for colon, rectal cancer which metastasized into bone cancer.It was further reported that the port was identified with fibrin sheath and the health care provider ordered a de-clotting agent to resolve this issue.The patient is reported to be stable.
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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: 01/2020.
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Search Alerts/Recalls
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