C.R. BARD, INC. (BASD) -3006260740 POWER PORT TI ISP, 8 FR. GROSHONG, INT W SP, SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8708560 |
Device Problems
Fracture (1260); Material Separation (1562); Migration (4003)
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Patient Problem
Embolism/Embolus (4438)
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Event Date 10/18/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately three months post a port placement, the catheter allegedly fractured.It was further reported that the catheter allegedly embolized inside the patient.The current status of the patient was 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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Event Description
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It was reported that two years, three months and twenty-five post a port placement, the catheter was allegedly fractured few centimeters from the port.It was further reported that the distal catheter had allegedly migrated to the left upper lobar pulmonary artery.Reportedly, the port septum and the catheter fragment was removed.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 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) 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.H10: d4 (expiration date: 09/2022), g3.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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Search Alerts/Recalls
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