C.R. BARD, INC. (BASD) -3006260740 HICKMAN PORT SINGLE LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0603880C |
Device Problems
Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889); Migration (4003)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/18/2023 |
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, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510 k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records was 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: 10/2025).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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Event Description
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It was reported that sometime post a port placement, the patient developed symptoms such as malignancy, chest tightness, and hypotension, and the symptoms disappeared after oxygen inhalation.It was further reported that the port catheter was transversed in the mediastinum, one end was located in the left suprahilar area and the other end was located in the right subhilar area and allegedly folded tortuously.Furthermore, it was also reported that the infusion port was allegedly ruptured and detached.Reportedly, foreign body removal was performed under local anesthesia in the catheterization laboratory and the catheter was removed.The current status of the patient is unknown.
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Search Alerts/Recalls
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