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 04/03/2024 |
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 12/2024).H11: section a through f - the information provided by bd represents all of 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 pending return.
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Event Description
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It was reported that nine months and twenty-four days post a port placement via the right internal jugular vein, the catheter and the port body were allegedly fallen off.It was further reported that the catheter allegedly got moved to the pulmonary artery.Reportedly, the patient has been transferred to the breast ward for observation, and was discharged.The current status of the patient is unknown.
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Search Alerts/Recalls
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