BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31G 6MM 30BOX MEX

    MDR report key: 10774501 · Received November 2, 2020

    Report

    Report Number
    9614033-2020-00152
    Event Type
    Malfunction
    Date Received
    November 2, 2020
    Date of Event
    October 9, 2020
    Report Date
    March 3, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    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. ONE PHOTO OF (2) 0.3ML BD INSULIN SYRINGES WAS PROVIDED. CONSUMER REPORTED THAT ONE OF THE SYRINGES IS WITH BAD PRINTING, AND IT SHOULD BE WASTED SINCE IT CANNOT MEASURE THE QUANTITY WITH ACCURACY. THE PHOTO WAS REVIEWED, AND IT WAS OBSERVED THAT ONE OF THE SYRINGES EXHIBITED MISSING SCALE MARKINGS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0062047. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WAS ONE (1) NOTIFICATION [200881799] NOTED FOR MISSING SCALE LINES. PRINT DRUM WAS DAMAGED AFFECTING THE PRINT ON THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE SYRINGE 0.3ML 31G 6MM 30BOX MEX HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "AT THE APPLYING OF THE MORNING, THE CUSTOMER FOUND THAT ONE OF THE SYRINGES IS WITH BAD PRINTING, AND IT SHOULD BE WASTED SINCE IT CAN NOT MEASURE THE QUANTITY WITH ACCURACY."

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER LAST NAME: (B)(6). 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 ONE SYRINGE 0.3ML 31G 6MM 30BOX MEX HAD SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "AT THE APPLYING OF THE MORNING, THE CUSTOMER FOUND THAT ONE OF THE SYRINGES IS WITH BAD PRINTING, AND IT SHOULD BE WASTED SINCE IT CAN NOT MEASURE THE QUANTITY WITH ACCURACY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241020 SYRINGE 0.3ML 31G 6MM 30BOX MEX PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 0062047

    Patients

    Seq Age Sex Outcome Treatment
    1