C.R. BARD, INC. (BASD) -3006260740 UNKNOWN POWER PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number UNKNOWN POWER PORT |
Device Problems
Fracture (1260); Material Separation (1562); Blocked Connection (2888); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/15/2022 |
Event Type
Injury
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Event Description
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It was reported that approximately one year post port placement procedure, the port was allegedly difficult to access.It was further reported that catheter was fractured and separated.Reportedly, the fragmented catheter was migrated into the right ventricle and pulmonary artery.The port catheter was removed.The current status of the patient is unknown.
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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 return of the sample is pending.The investigation of the reported event is currently underway.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provide 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 approximately one year post port placement procedure, the port was allegedly difficult to access.It was further reported that catheter was fractured and separated.Reportedly, the fragmented catheter was migrated into the right ventricle and pulmonary artery.The port catheter was removed.The current status of the patient is unknown.
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Search Alerts/Recalls
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