BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 21869547 · Received April 18, 2025

    Report

    Report Number
    2243072-2025-00550
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 7, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR CORRECTION. THE MANUFACTURING PLANT WAS INCORRECT IN THE INITIAL MDR. THE MANUFACTURING PLANT SHOULD BE BECTON DICKINSON DE MEXICO - CUAUTITLAN, IZCALLI, MEXICO/54730.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: UNKNOWN, BATCH#: UNKNOWN. RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4). PRODUCT SKU: 26001 - DNOSYR 3ML L/L, 153239- DNQSYRINGE 10ML LL BNS, 153245- DNQSYRINGE 5ML LL BNS. PRODUCT LOT NUMBER: UNKNOWN. COMPLAINT DETAILS: GOOD MORNING, ALL. I HAVE BEEN NOTIFIED AS OF THIS MORNING ON (B)(6) 2025 THAT THREE OF THE PHYSICIANS AT OUR FACILITY HAVE REPORTED SYRINGES SPECIFICALLY FROM OUT PROCEDURE TRAYS DYNJRA1955A HAVE BEEN LEAKING. THERE ARE NO REPORTS OF ANY OTHER OF OUR SYRINGE SUPPLIES HAVING THIS ISSUE, IT JUST SEEMS TO BE THE SYRINGES THAT ARE IN THE TRAYS. IT IS NOT ONE SIZE SYRINGE; IT APPEARS TO BE RANDOMLY ALL OF THEM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1787402 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown