BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE

    MDR report key: 15663632 · Received October 24, 2022

    Report

    Report Number
    8041187-2022-00611
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 19, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2083857. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. DEVICE MANUFACTURE DATE: 24-MAR-2022. MEDICAL DEVICE LOT #: 2055645. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027. DEVICE MANUFACTURE DATE: 24-FEB-2022. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WERE PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AT THE ASSEMBLY PROCESS, THERE IS A MECHANISM CONTROL TO CHECK FOR STOPPER LEAKAGE. THERE IS ALSO A DAILY QUALITY ASSURANCE ROUTING LEAK TEST INSPECTION IN PLACE TO CHECK FOR SYRINGE LEAKAGE. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 12 BD¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM MANDARIN CHINESE TO ENGLISH: RUBBER LEAKAGE, DRUG FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370479 BD¿ SYRINGE WITH PRECISIONGLIDE¿ NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown