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
Fluid/Blood Leak (1250); Fracture (1260); Material Separation (1562); Migration (4003)
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Patient Problems
Endocarditis (1834); Extravasation (1842); Embolism/Embolus (4438)
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Event Date 10/25/2023 |
Event Type
Injury
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Event Description
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It was reported that approximately two years post a power port placement, the catheter was allegedly fractured.It was further reported that the device allegedly embolized in the patient.Furthermore, there was allegedly a leak at the port hub and the patient experienced contrast extravasation into the surrounding tissues.Reportedly, the catheter and the port were 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: 12/2022).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 approximately two years post a power port placement, the catheter was allegedly fractured.It was further reported that the device allegedly embolized in the patient.It was also reported that there was allegedly a leak at the port hub and the patient experienced contrast extravasation into the surrounding tissues.Furthermore, the catheter tip allegedly broke off and migrated close to the right atrium and was successfully removed with an intravascular snare.However, the patient allegedly experienced serious adverse reaction of tricuspid endocarditis and was treated as per protocol.Reportedly, the catheter and the port were 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: b5, d4 (expiration date: 09/2024).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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