BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 24663545 · Received March 23, 2026

    Report

    Report Number
    9610847-2026-00130
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    January 30, 2026
    Report Date
    March 9, 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
    TX, US
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT HAD (B)(4) UNITS REJECTED FOR SUSPECTED PARTICULATES. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DMR # 671 PO #: (B)(6)_DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 20ML BD 10PK (REF. 305617) LOT NUMBER: 5181420 ITEM CODE: 305617 DEFECTIVE QUANTITY: (B)(4) DEFECT DESCRIPTION: SYRINGE LOT (5181420) AND HAD (B)(4) UNITS REJECTED FOR SUSPECTED PARTICULATES. OBSERVED DATE: JANUARY 30, 2026 OBSERVED DURING WHICH PROCESS STAGE: COMPOUNDING IR/ DMI NUMBER IF LAUNCHED: DEV-04261 SAMPLE AVAILABILITY FOR SUPPLIER TO INVESTIGATE: NO IS DEFECTIVE EVIDENCE (I.E. PICTURES; TEST RESULTS ETC.) AVAILABLE? YES IS PATIENT IMPACTED? NO IF DEFECT HAS BEEN REPORTED TO THIRD PARTY? NO IF THE DEFECT REPORT FROM XXX CUSTOMER? NO IS THERE A TREND OBSERVED? NO SUPPLIER ACTION AWARENESS/ ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251230 SYRINGE 20ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5181420 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1