BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL

    MDR report key: 12913883 · Received December 1, 2021

    Report

    Report Number
    9614033-2021-00142
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 2, 2021
    Report Date
    January 13, 2022
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 3ML LL , THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PHARMACY DEPARTMENT HAS SEQUESTERED LOT # ASSOCIATED WITH LEAKING SYRINGE TIPS (BD 1131289) AND REPLACED WITH TESTED LOT NUMBERS VERIFYING INTEGRITY OF SYRINGE. DEFECT WILL BE REPORTED TO MANUFACTURER AND PHARMACY WILL CONTINUE TO TRACK AND TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 3ML LL , THE DEVICE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PHARMACY DEPARTMENT HAS SEQUESTERED LOT # ASSOCIATED WITH LEAKING SYRINGE TIPS (BD (B)(4)) AND REPLACED WITH TESTED LOT NUMBERS VERIFYING INTEGRITY OF SYRINGE. DEFECT WILL BE REPORTED TO MANUFACTURER AND PHARMACY WILL CONTINUE TO TRACK AND TREND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1805088 BD SYRINGE 3ML LL PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 1131289 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown