BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENCKHOFF SPIRAL ACUTE PERITONEAL DIALYSIS CATHETER

    MDR report key: 8167934 · Received December 16, 2018

    Report

    Report Number
    1820334-2018-03777
    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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: CATHETER, PERITONEAL. PRODUCT CODE: GBW. CATALOG NUMBER: G29431, C-TAP-15-28-78-SPRL-5 AND G09266, C-TAPS-15-35-78-SPRL-4. 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 PLASTIC ADAPTORS INCLUDED IN THE PERITONEAL DIALYSIS CATHETER SET TENDS TO CRACK AND LEAK. THE ADAPTOR IS REPLACED WITH ANOTHER MANUFACTURER'S LOCKING TITANIUM ADAPTOR. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE. PER THE COMPLAINANT CLAIMS, "IN ADDITION, CHRONIC CATHETERS ARE NOT SUPPORTED BY THE LITERATURE ANY MORE BECAUSE THE SECOND CUFF CAN CAUSE NECROSIS AND INFLAMMATION AT THE INSERTION SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007209 TENCKHOFF SPIRAL ACUTE PERITONEAL DIALYSIS CATHETER FJS COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1