BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE S2 5ML

    MDR report key: 9844747 · Received March 17, 2020

    Report

    Report Number
    3002682307-2020-00097
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 309050 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOWS ONE OF OUR PRODUCT LABEL OF THE SHELF CARTON. NO DEFECT WAS OBSERVED. THE REPORTED ISSUE COMPLAINED BY THE CUSTOMER IS NOT RELATED TO A DEFECT OF THE PRODUCT AS IT RELATES TO THE MANUFACTURING PROCESS. THE MENTIONED "EXTRA ZERO" IS VISIBLE IN THE NUMBERS BELOW EACH BARCODE BECAUSE THE CONFIGURATION OF THE BARCODE MUST BE AN EVEN NUMBER. THIS ZERO IS INCLUDED BEFORE THE LOT NUMBER TO OBTAIN THAT BARCODE'S CONFIGURATION. THIS ISSUE HAPPENS IN ALL PRODUCTS AND BATCHES AND IS NOT A DEFECTIVE PRINT. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1911184.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE S2 5ML HAD AN INCORRECT BAR CODE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HERE YOU ARE A PRODUCT COMPLAINT , THE LOT NUMBER ON THE BAR CODE HAS AN ¿ EXTRA ¿ ZERO. THIS IS A DISTRIBUTOR AND WHEN THEIR SYSTEM READ THE BAR CODE THE LOT NUMBER IS DIFFERENT THAN OUR LOT NUMBER".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE S2 5ML HAD AN INCORRECT BAR CODE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HERE YOU ARE A PRODUCT COMPLAINT , THE LOT NUMBER ON THE BAR CODE HAS AN ¿ EXTRA ¿ ZERO. THIS IS A DISTRIBUTOR AND WHEN THEIR SYSTEM READ THE BAR CODE THE LOT NUMBER IS DIFFERENT THAN OUR LOT NUMBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309243 SYRINGE S2 5ML SYRINGE FMF BECTON DICKINSON, S.A. 1911184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other