BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 11168277 · Received January 13, 2021

    Report

    Report Number
    3006948883-2021-00085
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 11, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0202480. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT # 9169561. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 9262116. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 9197429. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 0019810. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 8233364. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 9050918. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 8305866. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 0063922. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 0168676. MEDICAL DEVICE EXPIRATION DATE: 2023-08-10. DEVICE MANUFACTURE DATE: 2020-07-20. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 428 INTIMA-II Y 24GAX0.75IN PRN/EC SLM CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS VISIBLE SILLICON OIL PARTICLE IN THE NEEDLE, AND SEVERAL BATCHES WERE INFLUENCED, THIS INCCIDENT WAS HAPPENED IN THE INTERNAL MEDICINE DEPARTMENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55139 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0168676

    Patients

    Seq Age Sex Outcome Treatment
    1