BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 29GA 1/2IN 200BX1600 HP CA

    MDR report key: 10131057 · Received June 8, 2020

    Report

    Report Number
    1920898-2020-00633
    Event Type
    Malfunction
    Date Received
    June 8, 2020
    Date of Event
    May 19, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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# 4121574. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THIS CATALOG WAS OBSOLETED AND DID NOT HAVE AN EXPIRATION DATE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1.0ML 29GA 1/2IN 200BX1600 HP CA EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 309311 LOT # 4121574 WITHOUT EXP DATE INFO. FOUND ITEMS WITHIN OLD STOCK. ADVISED PHARMACY THIS IS DISCONTINUED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: NA. 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 THE SYRINGE 1.0ML 29GA 1/2IN 200BX1600 HP CA EXPERIENCED MISSING LABEL INFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 309311 LOT # 4121574 WITHOUT EXP DATE INFO. FOUND ITEMS WITHIN OLD STOCK. ADVISED PHARMACY THIS IS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590779 SYRINGE 1.0ML 29GA 1/2IN 200BX1600 HP CA PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 4121574

    Patients

    Seq Age Sex Outcome Treatment
    1 Other