BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20 ML SYRINGE

    MDR report key: 12954301 · Received December 7, 2021

    Report

    Report Number
    3003152976-2021-00801
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 15, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE PICTURE RECEIVED IT CAN BE SEEN A LONGITUDINAL CRACK IN THE BARREL OF THE 20LL SYRINGE. NO OTHER HIT OR DAMAGE CAN BE SEEN IN THE DEVICE. DURING MANUFACTURING PROCESS TIGHTNESS TEST IS PERFORMED TO EVERY SYRINGE IN ASSEMBLY STATION. IN CASE ANY FAILS, IT IS REJECTED AUTOMATICALLY TO SCRAP. NO CHANGES IN MATERIALS HAVE BEEN PERFORMED THAT COULD HAVE LEAD TO THE DEFECT SEEN IN THE DEVICE. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON PRODUCT. REFERENCE 300220 IS A PRODUCT PACKAGED IN BULK, THAT IF ITS TRANSPORTED OR STORAGE UNDER PRESSURE CAN LEAD TO DAMAGE IN SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2003351, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH DAMAGE OR HIT ON PLUNGER DURING MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD 20 ML SYRINGE EXPERIENCED A FAILURE TO CONTAIN MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WAS FOUND TO BE CRACKED AND RESULTED IN FLUID LEAK. - THE ISSUE IDENTIFIED BEFORE PATIENT USE, NO PATIENT HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 20 ML SYRINGE EXPERIENCED A FAILURE TO CONTAIN MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WAS FOUND TO BE CRACKED AND RESULTED IN FLUID LEAK. THE ISSUE IDENTIFIED BEFORE PATIENT USE, NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850295 BD 20 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2003351

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown