BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5 ML X31GX6 MM B/P AP

    MDR report key: 12286021 · Received August 6, 2021

    Report

    Report Number
    1920898-2021-00867
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 16, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    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 A NUMBER OF IMAGES OF SHELF CARTONS FOR 0.5ML, 30 GAUGE, 8MM SYRINGES FROM LOT 0083452. THE PRINT FOR THE LOT NUMBER, MANUFACTURE DATE, AND EXPIRATION DATE IS MISSING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0083452. 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 LABEL INFORMATION MISSING. 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 SYRINGE 0.5 ML X31GX6 MM B/P AP DID NOT HAVE A LOT NUMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO LOT."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 SYRINGE 0.5 ML X31GX6 MM B/P AP DID NOT HAVE A LOT NUMBER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO LOT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186348 SYRINGE 0.5 ML X31GX6 MM B/P AP PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0083452

    Patients

    Seq Age Sex Outcome Treatment
    1