BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 11529815 · Received March 19, 2021

    Report

    Report Number
    1920898-2021-00319
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 8, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908418034
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8211561. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS HAD A LOOSE PLUNGER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLUNGER ROD IS LOOSE AND THE PLUNGER ROD COMES OUT OF THE SYRINGE WHEN DRAWING INSULIN. VERBATIM: CONSUMER REPORTED THAT THE PLUNGER ROD IS LOOSE AND COMES OUT OF THE SYRINGE WHEN SHE IS DRAW THE INSULIN."

    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 A SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS HAD A LOOSE PLUNGER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLUNGER ROD IS LOOSE AND THE PLUNGER ROD COMES OUT OF THE SYRINGE WHEN DRAWING INSULIN. VERBATIM: CONSUMER REPORTED THAT THE PLUNGER ROD IS LOOSE AND COMES OUT OF THE SYRINGE WHEN SHE IS DRAW THE INSULIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423448 SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328418 8211561 00382908418034

    Patients

    Seq Age Sex Outcome Treatment
    1