BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL

    MDR report key: 11096144 · Received December 30, 2020

    Report

    Report Number
    1920898-2020-01775
    Event Type
    Malfunction
    Date Received
    December 30, 2020
    Date of Event
    November 30, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311762
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 12/28/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G RELION SYRINGE IN AN OPEN POLY BAG FROM LOT # 0083446. CUSTOMER STATES THAT THE SYRINGE HAD A BROKEN PLUNGER, THUMB PRESS WAS BROKEN OFF AND FLANGE IS BROKEN OFF. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN PLUNGER ROD, BROKEN THUMB PRESS AND NO BROKEN FLANGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083446. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200886395, 200886116] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE AND CORRECTION: SYRINGES GOT CAUGHT IN THE DIAL. ASSOCIATE MANUALLY REMOVED THE OBVIOUS DAMAGED SYRINGE(S) FROM THE DIAL. ALL JAMMED SYRINGES NEED TO BE CLEARED FROM THE INDEX DIAL, SO THEY DO NOT CONTINUE DOWN THE FLOW PATH INTO THE POLYBAG. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328509 BATCH NO: 0083446. IT WAS REPORTED THAT THE SYRINGE HAD A BROKEN PLUNGER. ALSO, THE THUMB PRESS AND FLANGES WERE BROKEN OFF. VERBATIM: RELION CONSUMER REPORTED, FINDING A SYRINGE WITH BROKEN PLUNGER. STATED, THE "THUMB PRESS" AND "FLANGES" WERE BROKEN OFF. STATED, THERE WERE SOME "WHITE PIECES" LOSE IN BAG. 1 SYRINGE AFFECTED, (NOT ABLE TO USE).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA 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 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328509 BATCH NO: 0083446. IT WAS REPORTED THAT THE SYRINGE HAD A BROKEN PLUNGER. ALSO, THE THUMB PRESS AND FLANGES WERE BROKEN OFF. VERBATIM: RELION CONSUMER REPORTED, FINDING A SYRINGE WITH BROKEN PLUNGER. STATED, THE "THUMB PRESS" AND "FLANGES" WERE BROKEN OFF. STATED, THERE WERE SOME "WHITE PIECES" LOSE IN BAG. 1 SYRINGE AFFECTED, (NOT ABLE TO USE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1561196 SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328509 0083446 00681131311762

    Patients

    Seq Age Sex Outcome Treatment
    1