BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP

    MDR report key: 10881550 · Received November 22, 2020

    Report

    Report Number
    1920898-2020-01606
    Event Type
    Malfunction
    Date Received
    November 22, 2020
    Date of Event
    October 28, 2020
    Report Date
    March 5, 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

    H.6. INVESTIGATION: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. (B)(4) PHOTOS OF SHIPPERS AND SHELF CARTONS FOR SYRINGES FROM LOT 0041321 WERE PROVIDED. CUSTOMER REPORTED LOT NUMBER DISAPPEAR. THE PHOTOS WERE REVIEWED, AND IT WAS OBSERVED THAT THE LOT INFORMATION WAS MISSING ON 2 OF THE SHELF CARTONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0041321. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BECAUSE THE CARTON WAS CODED BUT IN THE WRONG LOCATION MEANS IT WAS INTRODUCED BACK INTO PRODUCTION BUT NOT PLACED CORRECTLY ON THE TRANSFER BELT BEFORE THE CODING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NUMBER DISAPPEAR.

    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 SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP WAS MISSING LABEL INFORMATION. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NUMBER DISAPPEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346741 SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP SYRINGE FMF BD MEDICAL - DIABETES CARE 0041321

    Patients

    Seq Age Sex Outcome Treatment
    1