Power Port MRI isp, 8 Fr. Groshong, Int w SP, Attachable SL
Received Jul 31, 2026 · Event occurred May 11, 2026
Report 3006260740-2026-05369 · MDR key 50094465
Device
Generic name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
8808560
Lot number
REKW1138
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Capsular Contracture
- Purulent Discharge
Narrative
Description of Event or Problem
A patient underwent a port placement procedure using a PowerPort M.R.I. ISP. Following thr procedure on (b)(6)2026, it was reported that the sutures appeared too close to the surface, with thick red scarring and exudate, requiring suture removal in Oncology. The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: 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. Section A through F: The information provide 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.