BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23797856 · Received December 13, 2025

    Report

    Report Number
    1911916-2025-00794
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 FOR DEVICE EVALUATION. IT WAS REPORTED THAT DOXORUBICIN LEAKED FROM THE OPPOSITE SIDE OF THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE HUNDRED EIGHTY-FOUR SAMPLES IN SEALED BLISTER PACKAGING WERE RECEIVED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION OF ALL SAMPLES REVEALED NO DEFECTS OR IMPERFECTIONS. THIRTY-TWO SAMPLES WERE RANDOMLY SELECTED FOR FUNCTIONAL ASSESSMENT; EACH UNDERWENT LEAK TESTING AND PASSED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302832, LOT 5212060. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER¿S REPORTED CONDITION COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 30ML LL S/C 56 HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302832. BATCH #5212060. VERBATIM: AS PER THE REPORT: RN WENT TO ADMINISTER DOXORUBICIN THAT WAS MADE FROM PHARMACY. NURSE WENT TO PUSH THE MEDICATION INTO PATIENTS IV. DOXOUBICIN SPILLED OUT OF THE OTHER SIDE OF THE SYRINGE AND SPILLED ONTO THE BLANKET THAT THE PATIENT HAD ON HIM. ANOTHER REPORT STATED: PRIMARY RN GAVE DOXORUBICIN IV PUSH VIA MEDIPORT WITH GOOD BLOOD RETURN. UPON COMPLETION OF FIRST SYRINGE OF DOXORUBICIN, PRIMARY RN PLACED SYRINGE IN CHEMO BIN. PT NOTICED ORANGE TINT ON HER SHOE. PRIMARY RN PRESUMED TINT TO BE DOXORUBICIN SPILL. THE IMPACTED PRODUCT IS SEQUESTERED AND WE WOULD LIKE TO SEND IT BACK FOR A QUALITY REVIEW. CAN YOU PLEASE ADVISE NEXT STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2712943 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212060 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown