C.R. BARD, INC. (BASD) -3006260740 GROSHONG PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603870C |
Device Problems
Disconnection (1171); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2022).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 two years, three months, and twenty days post a port placement in the right side of the seventh thoracic vertebrae via the right internal jugular vein, the infusion port catheter was allegedly separated.It was further reported that the free section catheter had allegedly migrated into the patient's right heart and left upper pulmonary vein.Furthermore, the patient was treated with digital subtraction angiography guided local anesthesia under angiography and disconnected infusion port catheter was captured.Reportedly, the catheter was severed and surgically removed.The patient is reported to be stable now.
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, groshong single-lumen, 7f that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, groshong single-lumen, 7f are identified in d2 and g4.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.Two electronic photos were provided for review.The photo shows the catheter fragment and a port connected to the catheter.The investigation is inconclusive for the reported disconnection and migration issue as the reported event cannot be confirmed from the provided photos.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiration date: 05/2022), (method) result, conclusion) 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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Event Description
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It was reported that two years, three months, and twenty days post a port placement in the right side of the seventh thoracic vertebrae via the right internal jugular vein, the infusion port catheter was allegedly separated.It was further reported that the free section catheter had allegedly migrated into the patient's right heart and left upper pulmonary vein.Furthermore, the patient was treated with digital subtraction angiography guided local anesthesia under angiography and disconnected infusion port catheter was captured.Reportedly, the catheter was severed and surgically removed.The patient is reported to be stable now.
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Search Alerts/Recalls
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