BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1.0ML 31GA 6MM

    MDR report key: 12579863 · Received October 5, 2021

    Report

    Report Number
    1920898-2021-01041
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 8, 2021
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1047957. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 1.0ML 31GA 6MM CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:  IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE BROKE OFF INTO THE VIAL WHEN ATTEMPTING TO DRAW INSULIN AND WAS ABLE TO REMOVE NEEDLE FROM VIAL. DATE OF EVENT : (B)(6) 2021. SAMPLE: YES.

    Additional Manufacturer Narrative · 1

    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 1 BD SYRINGE 1.0ML 31GA 6MM CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   IT WAS REPORTED BY THE CONSUMER THAT THE NEEDLE BROKE OFF INTO THE VIAL WHEN ATTEMPTING TO DRAW INSULIN AND WAS ABLE TO REMOVE NEEDLE FROM VIAL. DATE OF EVENT : (B)(6) 2021. SAMPLE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474111 BD SYRINGE 1.0ML 31GA 6MM PISTON SYRINGE FMF 1047957

    Patients

    Seq Age Sex Outcome Treatment
    1