C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0602830 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 07/24/2023 |
Event Type
Injury
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Event Description
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It was reported that one year and twenty-eight days post port placement and during a course of chemotherapy, there was extravasation of chemotherapy into the subcutaneous tissue of the patient.It was further reported that there was skin damage due to chemotherapy toxicity and the device removed and replaced.Reportedly, after removal of device, a rupture of the catheter silicone was identified.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: 01/2025) 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.
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Search Alerts/Recalls
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