BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE EXTENSION SET MICRO BORE

    MDR report key: 11369478 · Received February 23, 2021

    Report

    Report Number
    9610847-2021-00081
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 28, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851028
    PMA / PMN Number
    K013621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD Q-SYTE¿ EXTENSION SET MICRO BORE FROM LOT 0146033, AND 2 SETS FROM LOT 0171926, LEAKED AT THE JOINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "JOINT LEAKAGE".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0146033, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0171926, MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD Q-SYTE¿ EXTENSION SET MICRO BORE FROM LOT 0146033, AND 2 SETS FROM LOT 0171926, LEAKED AT THE JOINT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "JOINT LEAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263631 BD Q-SYTE EXTENSION SET MICRO BORE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 385102 SEE SECTION H.10. 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1