BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITONEAL DIALYSIS CATHETER

    MDR report key: 17527626 · Received August 12, 2023

    Report

    Report Number
    MW5134558
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    February 7, 2022
    Report Date
    February 18, 2022
    Manufacturer
    UNKNOWN
    Product Code
    FJS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT ON (B)(6) 2022, REPORTING A DRAIN COMPLICATION ENCOUNTERED, PLEASE CHECK PATIENT LINE (PL) AND DRAIN LINE (DL)MESSAGE OCCURRED IN DRAIN 0 (OCCURRED THREE TIMES). THE PATIENT WAS NOT SURE IF HE WAS EMPTY. THE PATIENT FURTHER EXPLAINED THAT HIS CATHETER WAS CHANGED TODAY AND THAT HE HAS NOT HAD TREATMENT SINCE SATURDAY. THE PATIENT WAS NOT SURE IF HE MAY OR MAY NOT HAVE ABSORBED HIS SOLUTION. TECH SUPPORT ADVISED TO CONTACT THE ON-CALL PD REGISTERED NURSE (RN) TO SEE IF HE MIGHT HAVE ABSORBED HIS SOLUTION AND IF IT WOULD BE OKAY TO MOVE FORWARD IN THE TREATMENT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT, AND NO MEDICAL INTERVENTION WAS REQUIRED. (B)(4). 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
    764328 PERITONEAL DIALYSIS CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown