BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22351982 · Received June 27, 2025

    Report

    Report Number
    1213809-2025-00447
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 4, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - SILICONE VISIBLE AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. 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. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP REPORT FOR ADDITIONAL INFORMATION. MW5171050 WAS RECEIVED THROUGH THE FDA¿S MEDWATCH PROGRAM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #302995 LOT #5093968, UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT 10 ML UNOPENED IV SYRINGES FOR IV COMPOUNDING WERE FOUND TO HAVE A VISCOUS FILM ON THE PLUNGER SEAL. IT APPEARS AS IF THE LUBRICANT THAT IS SUPPOSED TO BE AROUND THE CIRCUMFERENCE OF THE PLUNGER SEAL HAD MIGRATED INTO THE SPACE WHERE DRUG IS CONTAINED, POSING A RISK FOR CONTAMINATION. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. 10 ML UNOPENED IV SYRINGES FOR IV COMPOUNDING WERE FOUND TO HAVE A VISCOUS FILM ON THE PLUNGER SEAL. IT APPEARS AS IF THE LUBRICANT THAT IS SUPPOSED TO BE AROUND THE CIRCUMFERENCE OF THE PLUNGER SEAL HAD MIGRATED INTO THE SPACE WHERE DRUG IS CONTAINED, POSING A RISK FOR CONTAMINATION.

    Description of Event or Problem · 0

    MW5171050 WAS RECEIVED THROUGH THE FDA¿S MEDWATCH PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939054 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown