BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN SYRINGE

    MDR report key: 8667157 · Received June 4, 2019

    Report

    Report Number
    1920898-2019-00506
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 8162506. CUSTOMER STATES THAT THE UNIT MARKINGS ON THE SYRINGE WERE INCORRECT. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED MISSING OR PARTIALLY MISSING SCALE MARKINGS FROM THE 0-25 UNIT MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8162506. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200766128, 200766168] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. WHEN THE PRINTER DIALS ARE OUT OF TIME WITH EACH OTHER, IT CAN CAUSE THE TIP OF THE BARREL TO BE DAMAGED. WHEN THIS HAPPENS, THE BARREL DOES NOT SEAT PROPERLY IN THE CUP WHICH CAUSES PART OF THE BARREL TO NOT COME IN CONTACT WITH THE PRINT PAD, WHICH CAUSES THE MISSING PRINT. THERE WERE MULTIPLE MAINTENANCE DISPATCHES FOR DAMAGED TIPS DURING THE PRODUCTION OF THIS BATCH. THE TIMING OF THE DIALS WERE ADJUSTED TO CORRECT THE DAMAGED TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 8162506. IT WAS REPORTED THAT THE CONSUMER NOTICED UNIT MARKING ON THE SYRINGE WERE INCORRECT DURING INSULIN DRAW. HE RELEASED THE INSULIN BACK IN THE BOTTLE AND USED THE NEW SYRINGE FOR HIS INJECTION. VERBATIM: CONSUMER REPORTED HE NOTICED UNIT MARKING ON THE SYRINGE WERE INCORRECT DURING INSULIN DRAW. HE RELEASED THE INSULIN BACK IN THE BOTTLE AND USED THE NEW SYRINGE FOR HIS INJECTION. HE USES NEW SYRINGE FOR HIS INJECTION EACH TIME.

    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 SYRINGE HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 324911 BATCH NO: 8162506 IT WAS REPORTED THAT THE CONSUMER NOTICED UNIT MARKING ON THE SYRINGE WERE INCORRECT DURING INSULIN DRAW. HE RELEASED THE INSULIN BACK IN THE BOTTLE AND USED THE NEW SYRINGE FOR HIS INJECTION. VERBATIM: CONSUMER REPORTED HE NOTICED UNIT MARKING ON THE SYRINGE WERE INCORRECT DURING INSULIN DRAW. HE RELEASED THE INSULIN BACK IN THE BOTTLE AND USED THE NEW SYRINGE FOR HIS INJECTION. HE USES NEW SYRINGE FOR HIS INJECTION EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458721 BD ULTRA-FINE INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 8162506 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other