BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G

    MDR report key: 15166125 · Received August 4, 2022

    Report

    Report Number
    1920898-2022-00513
    Event Type
    Malfunction
    Date Received
    August 4, 2022
    Date of Event
    July 5, 2022
    Report Date
    August 10, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1144160, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2026, DEVICE MANUFACTURE DATE: 24-MAY-2021. MEDICAL DEVICE LOT #: 1242719, MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2026, DEVICE MANUFACTURE DATE: 30-AUG-2021. 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

    INVESTIGATION SUMMARY CUSTOMER RETURNED IMAGES OF TWO SEPARATE 0.3ML SYRINGES. NO LOT IDENTIFICATION WAS AVAILABLE FOR EITHER SYRINGE. ONE SYRINGE SHOWS A BEAD OF A CLEAR LIQUID TOWARD THE TIP OF THE SYRINGE ON ITS NEEDLE. THE OTHER SYRINGE HAS HAD THE THUMBPRESS ON THE PROXIMAL END OF THE PLUNGER ROD BREAK OFF. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCHS # 1144160 AND # 1242719 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE BROKEN THUMBPRESS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO TIMES THAT PRIOR TO USING THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G U-100 1/2 UNIT 100COUNT, THE THUMB PRESS WAS BROKEN OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, THE CUSTOMER FOUND THE THUMB PRESS WAS SEPARATE FROM PLUNGER ROD.

    Description of Event or Problem · 0

    IT WAS REPORTED TWO TIMES THAT PRIOR TO USING THE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G U-100 1/2 UNIT 100COUNT, THE THUMB PRESS WAS BROKEN OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, THE CUSTOMER FOUND THE THUMB PRESS WAS SEPARATE FROM PLUNGER ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381862 BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 6MM (15/64") 31G PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 SEE H.10. 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown