BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGES

    MDR report key: 8412368 · Received March 12, 2019

    Report

    Report Number
    1920898-2019-00249
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 25, 2019
    Report Date
    March 26, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903282906
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 8MM, 0.5 ML CC INSULIN SYRINGE. CUSTOMER STATES SCALE PRINT MISSING FROM SYRINGES. THE RETURNED SYRINGE WAS EXAMINED AND THE SCALE MARKINGS WERE FOUND TO BE PRINTED IN A TWISTED OR BOWING PATTERN AROUND THE BARREL; THE SCALE WAS ALSO PARTIALLY MISSING, THUS CONFIRMING THE ALLEGED DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113654. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. POSSIBLE ROOT CAUSES FOR MISSING SCALE MARKINGS INCLUDE: - DAMAGE TO THE PAD. - PRINT DRUM NOT TOUCHING THE PAD FOR INK TRANSFER. - PAD HEAT SET INCORRECTLY. - PRINT HEAD TIMING OUT OF ADJUSTMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ ULTRA-FINE INSULIN SYRINGES WAS MISSING SCALE PRINT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO: 328290, BATCH NO: 8205643. IT WAS REPORTED: THAT COSTUMER ENCOUNTERED MISSING SCALE PRINT FROM SYRINGES. VERBATIM: CONSUMER REPORTED SCALE PRINT MISSING FROM SYRINGES, OCCURRED A FEW WEEKS AGO. LOT # 8205643, EXP 07-31-2023, PRODUCT # 328290. SENDING MAIL KIT AND PRODUCT VOUCHER."

    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 WAS REPORTED THAT BD¿ ULTRA-FINE INSULIN SYRINGES WAS MISSING SCALE PRINT. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO: (B)(4), BATCH NO: 8205643. IT WAS REPORTED: THAT COSTUMER ENCOUNTERED MISSING SCALE PRINT FROM SYRINGES. VERBATIM: CONSUMER REPORTED SCALE PRINT MISSING FROM SYRINGES, OCCURRED A FEW WEEKS AGO. LOT # 8205643, EXP 07-31-2023, PRODUCT # 328290. SENDING MAIL KIT AND PRODUCT VOUCHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208135 BD ULTRA-FINE INSULIN SYRINGES INSULIN SYRINGE/NEEDLE FMF BD MEDICAL - DIABETES CARE 8205643 00382903282906

    Patients

    Seq Age Sex Outcome Treatment
    1 Other