BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24297521 · Received February 9, 2026

    Report

    Report Number
    9610847-2026-00052
    Event Type
    Malfunction
    Date Received
    February 9, 2026
    Date of Event
    January 22, 2026
    Report Date
    May 5, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056170
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. THIS PRODUCT IS NOT DESIGNED FOR STORAGE OF DRUGS/ SOLUTIONS AND REFRIGERATE THEM. DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND NO QN¿S (QUALITY NOTIFICATIONS) OR OTHER EVENTS WERE FOUND RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT BATCHING SYRINGES LEAKING DRUG AT THE PLUNGER AREA OF THE SYRINGE. RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: 22.01.2026 COMPLAINT NUMBER: (B)(4), ACCOUNT NUMBER: (B)(4), ITEM NUMBER: 308-305617, LOT # / SERIAL #: LOT# 5129980, EXPIRY 2030-04-30 LOT# 5195506 , EXPIRY 2030-06-30 SAMPLE AVAILABLE: YES ITEM DESCRIPTION: 20ML LUER-LOK TIP STERILE SYRINGE PACK INCIDENT DESCRIPTION: AS PER ACCOUNT, BATCHING SYRINGES LEAKING DRUG AT THE PLUNGER AREA OF THE SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46355 LUER-LOK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5129980 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1