BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 6MM 10BAG 500CS

    MDR report key: 11369851 · Received February 23, 2021

    Report

    Report Number
    1920898-2021-00216
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 29, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249114
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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: 3/18/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 6MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0111938. CUSTOMER STATES THAT THE PLUNGER THUMB PRESS IS BROKEN. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A BROKEN THUMB PRESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0111938. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 SYRINGE 0.5ML 31GA 6MM 10BAG 500CS HAD DAMAGED THUMB PRESSES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER FOUND TWO SYRINGES WITH THE PLUNGER THUMB PRESS BROKEN. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES WITH BROKEN PLUNGER THUMB PRESS. LOT #: 0111938 CATALOG#: 324911. DATE OF EVENT: UNKNOWN. SAMPLES STATUS AWAITING SAMPLE - 1 OUT THE 2 SYRINGES. NO REPLACEMENT AND INFORMED CONSUMER. SEVERAL CASES IN SNOW CONSUMER DEALS WITH (B)(6) PHARMACY".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 SYRINGE 0.5ML 31GA 6MM 10BAG 500CS HAD DAMAGED THUMB PRESSES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER FOUND TWO SYRINGES WITH THE PLUNGER THUMB PRESS BROKEN. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES WITH BROKEN PLUNGER THUMB PRESS. LOT #: 0111938. CATALOG#: 324911. DATE OF EVENT: UNKNOWN. SAMPLES STATUS AWAITING SAMPLE - 1 OUT THE 2 SYRINGES. NO REPLACEMENT AND INFORMED CONSUMER. SEVERAL CASES IN SNOW CONSUMER DEALS WITH KAISER PHARMACY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266406 SYRINGE 0.5ML 31GA 6MM 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324911 0111938 00382903249114

    Patients

    Seq Age Sex Outcome Treatment
    1