BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.3ML 31GA 6MM HALFUNIT

    MDR report key: 9500009 · Received December 19, 2019

    Report

    Report Number
    1920898-2019-01448
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    December 4, 2019
    Report Date
    January 8, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (5) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT MARKINGS ARE OFF ON THE BARREL, PRINTINGS ARE NOT LINED UP. ALL RETURNED SYRINGES WERE TESTED USING THE PLUG GAUGE AND ALL SCALE MARKING PLACEMENTS FALL WITHIN SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070627. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200819499, 200818801, 200819730, 200819826, 200818692] NOTED FOR SCRATCH PRINT. THERE WAS ONE (1) NOTIFICATION [200818447] NOTED FOR INK RINGS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 0.3ML 31GA 6MM HALFUNIT HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER STATED THAT MARKINGS ARE OFF ON THE BARREL, PRINTINGS ARE NOT LINED UP. VERBATIM: ISSUE: PARENT OF A CONSUMER REPORTED MARKINGS ARE OFF ON THE BARREL, PRINTINGS ARE NOT LINED UP. SHE STATED SHE HAS TO GIVE HER SON 5.5 UNITS OF INSULIN IN HER SONS TRESIBA, SHE CAN ESSENTIALLY DRAW 6.0 UNIT. SAMPLE AVAILABLE INCIDENT DATE-UNKNOWN; OCCURRENCE- UNKNOWN; ITEM# 324910; LOT# 9070627; EXPIRATION DATE-03-31-2024.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE 0.3ML 31GA 6MM HALFUNIT HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CONSUMER STATED THAT MARKINGS ARE OFF ON THE BARREL, PRINTINGS ARE NOT LINED UP. VERBATIM: ISSUE: PARENT OF A CONSUMER REPORTED MARKINGS ARE OFF ON THE BARREL, PRINTINGS ARE NOT LINED UP. SHE STATED SHE HAS TO GIVE HER SON 5.5 UNITS OF INSULIN IN HER SONS TRESIBA, SHE CAN ESSENTIALLY DRAW 6.0 UNIT. SAMPLE AVAILABLE INCIDENT DATE-UNKNOWN, OCCURRENCE- UNKNOWN, ITEM# 324910, LOT# 9070627; EXPIRATION DATE-03-31-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294663 BD SYRINGE 0.3ML 31GA 6MM HALFUNIT PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 9070627 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other