BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE

    MDR report key: 8832095 · Received July 26, 2019

    Report

    Report Number
    1920898-2019-00701
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 26, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00382908431033
    PMA / PMN Number
    K943683
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8240653. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8260822. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BETWEEN THE "6-7 UNIT" WAS UNCLEAR, AND THE STOPPER WAS SEPARATED BUT NOT COMPLETELY DETACHED. ALL DEFECTS WERE FOUND DURING USE, AND LOT#'S 8240653 AND 8260822 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE REPORTED OUT OF 2 BOXES SHE FOUND SYRINGES MARKING WAS NOT IN ANGEL. IT WAS NOT IN 90DEGREE ANGLE. SAMPLE AVAILABLE. ALSO, THE STOPPER (CONSUMER CALLED IT AS BLACK PLUNGER) WAS NOT IN ANGLE." CONSUMER REPORTED THE MARKING ON THE BARREL WAS NOT CLEAR BETWEEN 6-7 UNIT. SHE MANAGED TO USE IT. SHE NOTICED THE STOPPER WAS SEPARATED BUT NOT DETACHED.

    Additional Manufacturer Narrative · 1

    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 #: 8240653. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-08-28. MEDICAL DEVICE LOT #: 8260822. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-09-17. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE ON THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE BETWEEN THE "6-7 UNIT" WAS UNCLEAR, AND THE STOPPER WAS SEPARATED BUT NOT COMPLETELY DETACHED. ALL DEFECTS WERE FOUND DURING USE, AND LOT#'S 8240653 AND 8260822 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE REPORTED OUT OF 2 BOXES SHE FOUND SYRINGES MARKING WAS NOT IN ANGEL. IT WAS NOT IN 90 DEGREE ANGLE. SAMPLE AVAILABLE. ALSO, THE STOPPER (CONSUMER CALLED IT AS BLACK PLUNGER) WAS NOT IN ANGLE." CONSUMER REPORTED THE MARKING ON THE BARREL WAS NOT CLEAR BETWEEN 6-7 UNIT. SHE MANAGED TO USE IT. SHE NOTICED THE STOPPER WAS SEPARATED BUT NOT DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624078 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE SEE SECTION H.10. 00382908431033

    Patients

    Seq Age Sex Outcome Treatment
    1 Other