BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CATHETER

    MDR report key: 23943560 · Received January 2, 2026

    Report

    Report Number
    MW5181552
    Event Type
    Injury
    Date Received
    January 2, 2026
    Report Date
    December 23, 2025
    Manufacturer
    UNK
    Product Code
    PTV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAS ONLY PERFORMED CONTINUOUS AMBULATORY PD (CAPD) OR MANUAL PD THERAPY AND HAD NOT BEGUN UTILIZING A LIBERTY SELECT CYCLER. THE PDRN CONFIRMED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 DUE TO DRAIN COMPLICATIONS AND FLUID OVERLOAD DUE TO A MALFUNCTIONING PD CATHETER (NOT A (B)(6) PRODUCT). ALTHOUGH THE SPECIFICS ARE UNKNOWN, THE PATIENT¿S PD CATHETER WAS SURGICALLY REMOVED, AND A HEMODIALYSIS (HD) CATHETER (NOT A (B)(6) PRODUCT) WAS PLACED. THE PATIENT TRANSITIONED TO HD WITHOUT ANY KNOWN ISSUES AND WAS DISCHARGED TO A REHABILITATION HOSPITAL ON (B)(6) 2025 (DISCHARGED HOME ON (B)(6) 2025, BEGAN OUTPATIENT HD (B)(6) 2025). THE RATIONALE FOR THE TRANSITION WAS NOT PROVIDED, HOWEVER THE PDRN STATED IT WOULD BE PERMANENT. PER THE PDRN, THE SERIOUS ADVERSE EVENTS WERE NOT CAUSED BY ANY (B)(6) PRODUCT(S), DRUG(S), AND/OR DEVICE(S) DEFICIENCY OR MALFUNCTION. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13947 PD CATHETER CATHETER, PERITONEAL DIALYSIS, SINGLE USE, EXEMPT PTV UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown