BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24163480 · Received January 23, 2026

    Report

    Report Number
    9610847-2026-00024
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 10, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056187
    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

    IT WAS DETERMINED THAT MFR REPORT # 9610847-2026-00024 SUBMITTED FOR LOT # 5112150 WAS CREATED IN ERROR AND SHOULD BE CONSIDERED VOID.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT GROWTH/FOREIGN MATERIAL IS ON THE TOP OF PLUNGER. RCC RECEIVED A COMPLAINT VIA EMAIL. DATE: (B)(6) 2026, COMPLAINT NUMBER: (B)(4), ACCOUNT NUMBER: (B)(4) ACCOUNT NAME: XXXXX CONTACT PERSON: XXXXX ITEM NUMBER: 308-305618 LOT # / SERIAL #: (B)(6) SAMPLE AVAILABLE: CONFIRMING PICTURES: REQUESTING ITEM DESCRIPTION: 30ML LUER-LOK TIP STERILE SYRINGE PACK INCIDENT DESCRIPTION: AS PER CLIENT, HAVING THIS GROWTH LIKE MATERIAL AFTER FILLING. IT SHOWS CLOUDINESS AFTER FILLING. IN ONE OF THE PICTURES, IT'S VERY CLEAR THE GROWTH/FOREIGN MATERIAL IS ON THE TOP OF PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229249 LUER-LOK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5112150 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown