BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF SPIRAL ACUTE PERITONEAL DIALYSIS CATHETER

    MDR report key: 8167903 · Received December 16, 2018

    Report

    Report Number
    1820334-2018-03775
    Event Type
    Malfunction
    Date Received
    December 16, 2018
    Report Date
    December 16, 2018
    Manufacturer
    COOK INC
    Product Code
    FJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: CATHETER, PERITONEAL. PRODUCT CODE: GBW. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER WAS LEAKING. NO OTHER EVENT DETAILS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007193 TENCKHOFF SPIRAL ACUTE PERITONEAL DIALYSIS CATHETER FJS COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1