BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 23336855 · Received October 20, 2025

    Report

    Report Number
    1213809-2025-00659
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    August 20, 2025
    Report Date
    December 6, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903050604
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - LEAKAGE PAST STOPPER. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. PLASTIPAK 3 ML SYRINGE WITH BLUNT FILL NEEDLE USED TO DRAW UP IV REGLAN FROM VIAL. WHILE DRAWING UP MEDICATION, A "POP" SOUND WAS HEARD AND MOST OF MEDICATION WENT BACK INTO VIAL WITH SOME NOTED TO BE LEAKING OUT OF THE BOTTOM OF THE SYRINGE. SYRINGE APPEARS TO BE MALFORMED ON BOTTOM BASE. ITEM -305060, LOT - 5171212. CUSTOMER RESPONSE ON (B)(6) 2025. 1. IN THE MEDSUN REPORT (B)(4), THE EVENT DATE IS MENTIONED AS AUGUST 2025. COULD YOU PLEASE PROVIDE THE SPECIFIC DATE? 8/20/2025. 2. THE MEDSUN REPORT INDICATES THAT "OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS". WAS THERE ANY HARM/SERIOUS INJURY TO PATIENT/HCP? IF YES, PLEASE DESCRIBE IN DETAIL. NONE 3. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN INVESTIGATE FURTHER? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976381 PLASTIPAK LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5171212 00382903050604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown