C.R. BARD, INC. (BASD) -3006260740 POWERPORT M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 1808001 |
Device Problem
Migration (4003)
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Patient Problems
Itching Sensation (1943); Rash (2033); Burning Sensation (2146); Swelling/ Edema (4577)
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Event Date 01/27/2023 |
Event Type
Injury
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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) are 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.Expiration date: 07/2023.Device not returned.
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Event Description
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It was reported that sometime post port placement procedure, the device allegedly migrated.Reportedly, the patient experienced rash, itching, burning, redness and swelling around the port access area.The current patient status was unknown.
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Search Alerts/Recalls
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