BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24334275 · Received February 13, 2026

    Report

    Report Number
    9610847-2026-00063
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 3, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY CONFIRMED SILICONE OIL PRESENCE ASSOCIATED WITH THE SUPPLIED COMPONENT LOT. RCC RECEIVED A COMPLAINT VIA EMAIL. DMR # (B)(4) PO #: (B)(4) DEFECT MATERIAL DESCRIPTION: SYRINGE TRAY, 20ML BD 10PK (REF. 305617) LOT NUMBER: 5195502, 5181420, ITEM CODE: 305617, DEFECTIVE QUANTITY: 2 , DEFECT DESCRIPTION: THIS DMR IS INITIATED TO FORMALLY NOTIFY THE SYRINGE SUPPLIER OF CONFIRMED (B)(4) WITH THE SUPPLIED COMPONENT LOT, IDENTIFIED DURING INTERNAL QUALITY INVESTIGATION. ALTHOUGH NO PARTICULATE MATTER WAS CONFIRMED BY FTIR ANALYSIS OR QC VISUAL ASSESSMENT, THE INVESTIGATION CONCLUDED THE OBSERVED DEFECT WAS SILICONE OIL. WE WISH TO REQUEST FOR SILICON OIL ADDITION SPECIFICATION AND THE SAFETY JUSTIFICATION REPORT/DATA (MEDICAL GRADE/ INERT, BIOCOMPATIBLE, ETC) OBSERVED DATE: (B)(6) 2026 OBSERVED DURING WHICH PROCESS STAGE: ILP IR/ DMI NUMBER IF LAUNCHED: (B)(4) 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 , SUPPLIER ACTION AWARENESS/ ATTENTION

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273630 LUER-LOK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5181420 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1