BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 8MM

    MDR report key: 12210838 · Received July 22, 2021

    Report

    Report Number
    1920898-2021-00809
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL IMAGES SHOWING SHELF CARTONS FOR 0.5ML, 30 GAUGE, 8MM SYRINGES FROM LOT 0307355. THE CARTONS FEATURE CRUMPLED CORNERS AS WELL AS A ROUGH GASH ON THE TOP CORNER OF ONE OF CARTONS. ADDITIONALLY, ONE CARTON FEATURES A MISPRINTED SECTION OF THE LOT, MANUFACTURING, AND EXPIRATION DATES. THE TEXT IS FAINT AND ILLEGIBLE ACROSS THIS AREA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0307355. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF SHELF CARTON DAMAGE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 SYRINGE 0.5ML 30GA 8MM HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : NO LOT NUMBER = 1 SP.

    Additional Manufacturer Narrative · 1

    (B)(6). INITIAL REPORTER ZIP CODE: UNKNOWN. A DEVICE EVALUATION IS PENDING 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 1 SYRINGE 0.5 ML 30GA 8 MM HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO LOT NUMBER = 1 SP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108270 SYRINGE 0.5ML 30GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0307355

    Patients

    Seq Age Sex Outcome Treatment
    1