BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL CLEAR 14GA 1-1/4IN

    MDR report key: 12481398 · Received September 16, 2021

    Report

    Report Number
    3003152976-2021-00601
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 20, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY PHOTOS RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION IT CAN BE SEEN THE PICTURES WERE TAKEN WITH THE BISTER CLOSED. DAMAGE IN THE BARREL OF THE SYRINGE CAN BE NOTICED, ADDITIONALLY LOT NUMBER AND TOP WEB OF THE UNITARY PACKAGING ARE ALSO SHOWN IN THE PICTURES. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH DAMAGE PRODUCED IN THE ASSEMBLY PROCESS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1912211. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES.

    Description of Event or Problem · 0

    IT WAS REPORTED SYRINGE 50ML LL CLEAR 14GA 1-1/4IN WAS UNABLE TO CONTAIN BLOOD/MEDICATION DUE TO A CRACK OR HOLE IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "DEFECTIVE PRODUCTS DETECTED IN JULY 2021".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 50ML LL CLEAR 14GA 1-1/4IN WAS UNABLE TO CONTAIN BLOOD/MEDICATION DUE TO A CRACK OR HOLE IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "DEFECTIVE PRODUCTS DETECTED IN (B)(6) 2021"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1377933 SYRINGE 50ML LL CLEAR 14GA 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1912211

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown