BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 10882198 · Received November 22, 2020

    Report

    Report Number
    1920898-2020-01607
    Event Type
    Injury
    Date Received
    November 22, 2020
    Date of Event
    October 28, 2020
    Report Date
    April 1, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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# 0083518. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200886335, 200886538] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WAS INVOLVED IN A NEEDLESTICK DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGES BEND DURING THE INJECTION AND WHEN DRAWING FROM THE VIAL. ALSO, THE CONSUMER POKED HERSELF. VERBATIM: PET OWNER REPORTED EVERYDAY THE SYRINGE NEEDLES ARE BENDING DURING INJECTIONS. STATED THE NEEDLE ALSO BENDS WHEN TRYING TO DRAW INSULIN FROM THE VIAL. STATED SHE POKED HERSELF WITH THEM AS WELL."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL WAS INVOLVED IN A NEEDLESTICK DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGES BEND DURING THE INJECTION AND WHEN DRAWING FROM THE VIAL. ALSO, THE CONSUMER POKED HERSELF. VERBATIM: PET OWNER REPORTED EVERYDAY THE SYRINGE NEEDLES ARE BENDING DURING INJECTIONS. STATED THE NEEDLE ALSO BENDS WHEN TRYING TO DRAW INSULIN FROM THE VIAL. STATED SHE POKED HERSELF WITH THEM AS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347379 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 0083518 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other