BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 18941165 · Received March 20, 2024

    Report

    Report Number
    3003152976-2024-00179
    Event Type
    Malfunction
    Date Received
    March 20, 2024
    Date of Event
    March 12, 2024
    Report Date
    May 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION: FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF PR (B)(4) AND WILL BE CANCELLED, VOIDING THIS MDR.

    Description of Event or Problem · 0

    IF YOUR DEPARTMENT DOES NOT USE A 50ML LUER LOCK PLASTIPAK SYRINGE WITH REF: (B)(4), THE E-MAIL BELOW DOES NOT APPLY TO YOU. TODAY A COMPLAINT WAS REPORTED FROM A DEPARTMENT ABOUT JHA ARTICLE 1014147 THE 50ML PLASTIPAK LUER LOCK SYRINGE WITH REF (B)(4) AND LOT NUMBER 2401034. WITH THESE SYRINGES, A STICKY SUBSTANCE WAS FOUND ON THE PESTLE, WHICH YOU CAN ALSO SEE AGAINST THE WALL OF THE SYRINGE AS SHOWN IN THE PHOTOS IN THE ATTACHMENT. THERE IS ALWAYS A MINUSCULE LAYER ON THE PESTLE TO MAKE THE SYRINGE WORK SMOOTHLY. IN ALL LIKELIHOOD, ACCORDING TO THE SUPPLIER, TOO MUCH SUBSTANCE HAS ENDED UP ON THE PESTLE. THE SYRINGES ARE OF COURSE BEING EXAMINED AND THE REPORT HAS ALREADY BEEN PICKED UP BY THE SUPPLIER TODAY. THE ADVICE IS NOT TO USE SYRINGES THAT CONTAIN TOO MUCH SUBSTANCE, BUT TO KEEP THEM. FOR NOW, ACCORDING TO THE SUPPLIER, IT IS NOT NECESSARY TO REMOVE ALL SYRINGES WITH LOT NUMBER 2401034 FROM STOCK. IT IS IMPORTANT TO DO A VISUAL CHECK AS USUAL BEFORE USE. THE REQUEST TO DRAW THE ATTENTION OF ALL USERS TO THIS. IF SYRINGES WITH AN EXCESS OF SUBSTANCE ARE FOUND IN YOUR DEPARTMENT, PLEASE SEND ME AN E-MAIL AND KEEP THE SYRINGE. IF IT TURNS OUT THAT MORE ACTION IS NEEDED, YOU WILL BE NOTIFIED AS SOON AS POSSIBLE. IF YOU HAVE ANY QUESTIONS ABOUT THIS EMAIL, PLEASE LET ME KNOW. ADDITIONAL INFORMATION: COULD YOU PLEASE PROVIDE A DATE OF EVENT? WEEK 11.

    Description of Event or Problem · 0

    THIS COMPLAINT IS A DUPLICATE OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436618 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2401034 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown