BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASTIPAK LUER-LOK

    MDR report key: 22878058 · Received August 22, 2025

    Report

    Report Number
    1213809-2025-00570
    Event Type
    Malfunction
    Date Received
    August 22, 2025
    Date of Event
    August 11, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - PLUNGER ROD BROKEN / DAMAGED IT WAS REPORTED THAT THE PLUNGER OF A SYRINGE BROKE IN HALF DURING THE ADMINISTRATION OF MEDICATION. TO SUPPORT THE INVESTIGATION, THREE 3 ML LUER-LOK SYRINGES WITH BLUNT FILL NEEDLES ATTACHED, ALONG WITH TWO PHOTOGRAPHS, WERE SUBMITTED TO THE QUALITY TEAM FOR EVALUATION. UPON INSPECTION, ONE SYRINGE WAS FOUND TO BE FREE OF DEFECTS OR ABNORMALITIES. THE OTHER TWO SYRINGES EXHIBITED SIGNIFICANT DAMAGE, INCLUDING PUNCTURE HOLES IN THE BARREL AND DEFORMATION OF THE PLUNGER ROD. THE PHOTOGRAPHS SHOW ONE LOOSE SYRINGE IN EACH IMAGE¿ONE WITH A DAMAGED BARREL AND THE OTHER WITH A DAMAGED PLUNGER ROD THAT HAD BEEN PULLED FROM THE BARREL. THE OBSERVED DAMAGE IS NON-CONFORMING TO PRODUCT SPECIFICATIONS AND APPEARS TO BE ASSOCIATED WITH THE ASSEMBLY PROCESS, MOST LIKELY RESULTING FROM THE UNIT BEING PINCHED BETWEEN TWO DIALS DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 305060, LOT 5150321, CONFIRMED THAT ALL VISUAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH ESTABLISHED REQUIREMENTS. NO QUALITY NOTIFICATIONS OR DEVIATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT WAS INSPECTED AND ACCEPTED PER THE INSPECTION CONTROL PLAN, APPROVED FOR SHIPMENT, AND DEEMED COMPLIANT WITH PRODUCT SPECIFICATION REQUIREMENTS. TO DATE, NO ADDITIONAL SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305060, BATCH#: 5150321. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM # 305060. LOT # 5150321. ON THREE OCCASIONS, THE NURSE NOTICED THE SYRINGES WERE DEFECTIVE. THE RN REPORTED THAT THE PLUNGER BROKE IN HALF DURING THE ADMINISTRATION OF THE MEDICATION. THE BARREL STARTED LEAKING MEDICATION PRIOR TO GIVING AN INJECTION BECAUSE THE PLUNGER HAD BROKEN. NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2619097 PLASTIPAK LUER-LOK PISON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5150321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown