BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 21334697 · Received February 7, 2025

    Report

    Report Number
    1213809-2025-00076
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 15, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - SCALE MARKING ISSUE. ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS TWO FULLY ASSEMBLED 3 ML LL SYRINGES WITH NEARLY ALL SCALE MARKINGS MISSING. THIS CONDITION IS NON-CONFORMING TO THE PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS EITHER ONE DOT, TWO DOTS OR NONE AND THEY OCCUR IN THE SAME PLACE. THIS PROBLEM AFFECTS MULTIPLE ITEMS AND IT IS ON ALL THE BATCHES WE HAVE IN STOCK. SO FAR IT HAS BEEN REPORTED TO US ON ITEMS 3001489 (301073), 3001490 (301027) AND 3009101 (309648). THIS IS INFO I´VE RECEIVED FROM OUR PRODUCTION. WE WERE INFORMED BY THE FACTORY THAT THE SYRINGES FROM THE MANUFACTURER BD HAVE BLACK DOTS ON THEM. THERE IS EITHER ONE DOT, TWO DOTS OR NONE AND THEY OCCUR IN THE SAME PLACE. THIS PROBLEM AFFECTS SEVERAL ARTICLES AND IT IS ON ALL BATCHES THAT WE HAVE IN STOCK. SO FAR THIS HAS BEEN REPORTED TO US FOR ITEMS 301073(3001489), 301027(3001490) AND 309648(3009101). THE DOTS ARE LOCATED ON THE OUTSIDE AND WE BELIEVE THAT THIS MAY BE SOME KIND OF MARKING. HOWEVER, THIS IS NOT A SERIOUS DEFECT AND THE ARTICLES CAN CONTINUE TO BE USED. WE ALSO FOUND SYRINGES ON WHICH THE SCALE IS LESS VISIBLE OR NOT VISIBLE AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902896 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown