C.R. BARD, INC. (BASD) -3006260740 UNKNOWN PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNK PORT |
Device Problems
Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Suction Problem (2170); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/25/2024 |
Event Type
Injury
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Event Description
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It was reported that sometimes post a port placement, the port was allegedly not working.It was further reported that when removing the port and the catheter, the catheter was not intact as a whole and the distal end of the catheter was allegedly found to be broken off.Furthermore, the broken piece of the catheter had traveled through the right atrium across the tricupsid valve through the right ventricle and allegedly got lodged at the pulmonary artery.Reportedly, the patient had to go to the catheterization laboratory for removal of the distal end of the catheter.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: 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.H3 other text : device not returned.
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Search Alerts/Recalls
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