BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24597965 · Received March 13, 2026

    Report

    Report Number
    9610847-2026-00100
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    January 14, 2026
    Report Date
    May 4, 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 BD 20ML SYRINGE LOT 5181420, IR SPECTRUM DEMONSTRATED A 79.2 MATCH TO SILICONE LUBRICANT AND, WHEN COMPARED TO THE BROADER FTIR LIBRARY, A 93.7 MATCH TO SILASTIC Q7 4550, A PEROXIDE CURED MEDICAL GRADE SILICONE ELASTOMER CONSISTENT WITH STOPPER CONSTRUCTION. RCC RECEIVED A COMPLAINT VIA EMAIL. DMR # (B)(4) PO #: (B)(4) DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 20ML BD 10PK (REF. 305617) LOT NUMBER: 5181420 ITEM CODE: 305617 DEFECTIVE QUANTITIES: 1 DEFECT DESCRIPTION: BD 20ML SYRINGE LOT 5181420, IR SPECTRUM DEMONSTRATED A 79.2 MATCH TO SILICONE LUBRICANT AND, WHEN COMPARED TO THE BROADER FTIR LIBRARY, A 93.7 MATCH TO SILASTIC Q7 4550, A PEROXIDE CURED MEDICAL GRADE SILICONE ELASTOMER CONSISTENT WITH STOPPER CONSTRUCTION. NO UNITS ARE AVAILABLE TO BE RETURNED. OBSERVED DATE: (B)(6) 2026 OBSERVED DURING WHICH PROCESS STAGE: ILP IR/ DMI NUMBER IF LAUNCHED: DEV-04209 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 QUVA CUSTOMER? NO IS THERE A TREND OBSERVED? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484555 LUER-LOK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5181420 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown