C.R. BARD, INC. (BASD) -3006260740 UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNK PORT |
Device Problems
Fracture (1260); Material Separation (1562); Migration (4003)
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Patient Problems
Neck Pain (2433); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/11/2024 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not 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.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that two months and twenty-eight days post a port placement, when the port was accessed and flushed, the patient allegedly experienced intense pain in the neck behind the ear.It was further reported that the port was allegedly found to be fractured under x-ray imaging.Furthermore, the port catheter fractured at pinch off point with catheter fragment had allegedly looped in the right ventricle.The current status of the patient is unknown.
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Search Alerts/Recalls
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