C.R. BARD, INC. (BASD) -3006260740 POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8808560 |
Device Problems
Entrapment of Device (1212); Fracture (1260); Material Separation (1562)
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Patient Problems
Perforation of Vessels (2135); Foreign Body In Patient (2687)
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Event Date 11/07/2023 |
Event Type
Injury
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Event Description
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It was reported that nine years, eleven months, and eighteen days post a port placement, the catheter was allegedly fractured and was allegedly snapped off leaving eleven centimeter of the catheter inside the patient.It was further reported that the tip of the catheter was allegedly impregnated in the superior vena cava vessel wall and would not budge with good amount of force.Reportedly, the septum was removed and the broken off catheter piece was left in-situ in the vessel.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 (expiry date: 05/2015).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 nine years, eleven months, and eighteen days post a port placement, the catheter was allegedly fractured and was allegedly snapped off leaving eleven centimeter of the catheter inside the patient.It was further reported that the tip of the catheter was allegedly impregnated in the superior vena cava vessel wall and would not budge with good amount of force.Reportedly, the septum was removed and the broken off catheter piece was left in-situ in the vessel.The current status of the patient is unknown.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiry date: 05/2015).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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