BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CATHETER

    MDR report key: 17605513 · Received August 22, 2023

    Report

    Report Number
    MW5144890
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    August 3, 2023
    Report Date
    August 21, 2023
    Manufacturer
    UNK
    Product Code
    FJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023, A PATIENT ON PERITONEAL DIALYSIS (PD) REPORTED EXPERIENCING A ¿M-31 AIR DETECTED IN CASSETTE¿ MESSAGE DURING AN UNKNOWN PHASE OF PD TREATMENT WITH THE (B)(6) CYCLER THE NIGHT BEFORE. THERE WERE NO REPORTED ISSUES WITH THE (B)(6) CYCLER. RATHER, THE PATIENT REPORTED THAT A PIECE OF THE PD CATHETER (NOT A (B)(6) PRODUCT) BROKE AND CAUSED A FLUID LEAK. IN ADDITIONAL FOLLOWUP WITH TWO PD NURSES FAMILIAR WITH THE PATIENT, IT WAS CONFIRMED THAT THE PD CATHETER MALFUNCTIONED WITH OMENTUM GROWING AROUND THE CATHETER AND A HOLE DEVELOPING. IT WAS STATED THE LEAK WAS A DIRECT RESULT OF THE PD CATHETER AND NOT RELATED TO (B)(6) PRODUCTS. THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS AND DID NOT DEVELOP PERITONITIS. THE PATIENT WAS HOSPITALIZED FOR PD CATHETER MALFUNCTION AND WAS SUBSEQUENTLY TRANSITIONED TO HEMODIALYSIS FOR RENAL REPLACEMENT NEEDS. 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
    301099 PD CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown