BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 22768123 · Received August 10, 2025

    Report

    Report Number
    1911916-2025-00564
    Event Type
    Malfunction
    Date Received
    August 10, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED, 5066924 & 5090154.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP IT WAS REPORTED THAT THE LUER LOCK TIP BROKE PRIOR TO ADMINISTRATION. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, THREE PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGES DEPICTED A PACKAGING BLISTER TOP WEB LABELED WITH LOT NUMBER 5066924, A PHASEAL CONNECTOR WITH A FRAGMENT OF A SYRINGE BARREL LUER LOK, AND A SYRINGE BARREL WITH THE LUER LOK VISIBLY BROKEN OFF. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED IN THE PROVIDED IMAGES. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302830, COVERING THE POTENTIALLY ASSOCIATED LOT NUMBERS 5066924 AND 5090154. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE MANUFACTURING PROCESSES OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THESE LOTS. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE REPORTED ISSUE HAS BEEN CONFIRMED. HOWEVER, DUE TO THE ABSENCE OF THE PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT IS REPORTED BROKEN LUER LOCK TIP. EVENT DESCRIPTION: AS PER ACCOUNT, A BD 20 ML SYRINGE (MODEL #302830) CONTAINING DARATUMUMAB FOR SUBCUTANEOUS ADMINISTRATION BROKE AT THE LUER LOCK TIP PRIOR TO ADMINISTRATION IN THE XXX. THIS OCCURRED DURING STANDARD USE WHILE THE NURSE CONNECTED THE SYRINGE TO THE BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE (CSTD). AS THE MALE PHASEAL LOCKED INTO THE FEMALE CONNECTOR, UNTIL THE TYPICAL "CLICK" WAS HEARD, THE SYRINGE TIP SNAPPED. IMMEDIATE CONTAINMENT ACTIONS WERE TAKEN BY THE NURSE AND THERE WAS NO DRUG EXPOSURE TO STAFF OR PATIENTS. POTENTIALLY IMPACTED LOTS (5066924, 5090154).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109261 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown