BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGREAT LAMBDA

    MDR report key: 15496192 · Received September 28, 2022

    Report

    Report Number
    3009500972-2022-00011
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    August 26, 2022
    Report Date
    September 27, 2022
    Manufacturer
    TERUMO CLINICAL SUPPLY CO., LTD.
    Product Code
    DQO
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME: ZIZAI, PRODUCT CODE: KRA (ZIZAI'S DEVICE FAMILY, PROGREAT IS REGISTERED WITH BOTH DQO AND KRA), PRODUCT CODE NAME: CATHETER, CONTINUOUS FLUSH, IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. THE DEVICE HISTORY RECORDS OF THE LOT 210800390 WERE REVIEWED, AND NO DISORDER THAT MAY CAUSE THE POOR REMOVAL OF THE INVOLVED DEVICE WAS FOUND. WE INSPECTED THE TREND ABNORMALITIES FOR THIS PRODUCT, AND NO TREND ABNORMALITIES RELATED TO THE POOR REMOVAL OCCURRED IN THE PAST. SINCE THE INVOLVED DEVICE WAS NOT RETURNED AND NO ABNORMALITY WAS FOUND FROM THE INVESTIGATION RESULTS, WE COULD NOT IDENTIFY THE CAUSE OF THE POOR REMOVAL THAT OCCURRED IN THE INVOLVED DEVICE. TERUMO MEDICAL PRODUCTS (TMP)(IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO CLINICAL SUPPLY CO., LTD. (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE ZIZAI PRODUCT INVOLVED WAS USED, THE GUIDE WIRE PENETRATED THE SIDE OF ZIZAI. THE ZIZAI WAS BENT AT A RIGHT ANGLE AS THE GUIDE WIRE WITH A STIFF TIP WAS USED, IT WAS THOUGHT THAT IT HIT AND PENETRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1951199 PROGREAT LAMBDA MICRO CATHETER SYSTEM DQO TERUMO CLINICAL SUPPLY CO., LTD. N/A 210800390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown