BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 13510291 · Received February 10, 2022

    Report

    Report Number
    3010617000-2022-00134
    Event Type
    Malfunction
    Date Received
    February 10, 2022
    Date of Event
    December 30, 2021
    Report Date
    February 10, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS NOT YET RECEIVED THE CATHETER IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    AS REPORTED, THE SOLEX 7 CATHETER (LOT # 162818) WAS "SHREDDED WHILE TRYING TO THREAD IT." THE CUSTOMER MIGHT MEAN THE BALLOON UNRAVELED OR BALLOON INTEGRITY WAS COMPROMISED. ZOLL BELIEVES THAT THIS HAPPENED DURING CATHETER INSERTION. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. THEREFORE, ZOLL DOES NOT HAVE INFORMATION ABOUT USER TECHNIQUES OR AT WHAT STAGE DURING INSERTION IT HAPPENS. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081449 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 162818 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown