BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRESCENT JUGULAR DUAL LUMEN CATHETER 32FR

    MDR report key: 12681704 · Received October 22, 2021

    Report

    Report Number
    3011468686-2021-00010
    Event Type
    Death
    Date Received
    October 22, 2021
    Date of Event
    September 22, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED WITH A TOTAL OF 6 SUTURE SITES, 1 ON THE GOLD SUTURE SAFE REINFORCEMENT AND THE REMAINING ON THE WIRE REINFORCED PORTION OF THE CATHETER BODY (THIS IS WARNED AGAINST IN IFU) . SUTURE COLLAR WAS NOT PRESENT. PAD PRINTING ON THE INFUSION AND DRAINAGE LUMENS WAS MOSTLY MISSING WHICH SUGGESTS EXPOSURE TO A SOLVENT OR CLEANING MATERIAL. THE RETURNED CATHETER WAS MEASURED AND MEASUREMENTS FOUND TO BE CONSISTENT WITH 30FR CATHETER RATHER THAN THE 32FR SIZE REPORTED. URETHANE MATERIAL WAS OBSERVED ABOVE AND BELOW THE SPRING PER CATHETER BODY SPECIFICATIONS. FATIQUE/KINK, SUTURE SAW THROUGH, SCALPEL PUNCTURE PROPOGATION, AND EXPOSURE TO SOLVENT COULD NOT BE RULED OUT AS POTENTIAL ROOT CAUSE OF BREACH THEREFORE, ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    PATIENT CANNULATED AT (B)(6) MEDICAL CENTER, DATE OF CANNULATION AND INSERTION METHOD ARE UNKNOWN. CATHETER FRACTURED WHILE INSIDE PATIENT. PATIENT WAS NOT RECANNULATED. HOSPITAL REPORTED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580844 CRESCENT JUGULAR DUAL LUMEN CATHETER 32FR DUAL LUMEN CATHETER 32FR PZS MC3 INC. 70132

    Patients

    Seq Age Sex Outcome Treatment
    1 Death