C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806060 |
Device Problems
Fracture (1260); Material Separation (1562); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/28/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 02/2023).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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Event Description
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It was reported that some time post a port placement in the right side of the sixth thoracic vertebra via the left internal jugular vein, the catheter allegedly broke at the puncture site.It was further reported that the broken catheter allegedly fell into the heart.Reportedly, surgery was done to retrieve the broken catheter as well as the defective device was removed and replaced.The current status of the patient is unknown.
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Search Alerts/Recalls
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