BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 25084384 · Received May 5, 2026

    Report

    Report Number
    1213809-2026-00237
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THAT BD SYRINGE 1ML LL CONTAINED FOREIGN MATTER. COMPLAINT VIA EMAIL. PLEASE INITIATE A COMPLAINT INVESTIGATION AND HAVE IT COMPLETED WITHIN 45-60 DAYS REFERENCING FOR ¿FOREIGN PARTICULATE¿. THIS IS FOR SYRINGE LOTS: 5056026, 3011963. I AM TRYING TO CONFIRM IF PHOTOS OR A COMPLAINT SAMPLE ARE AVAILABLE. DESCRIPTION 17APR2026 - THE FOLLOWING WAS RECEIVED VIA XXX VIA LSMV INTO THE TWD DESCRIPTION FIELD ON 17APR2026: "INTRAVITREAL SOLUTION; UNKNOWN". 17APR2026 - BASED ON THE PV DATABASE NUMBER RECEIVED FROM IN THIS INQUIRY RECORD, THIS EVENT IS A DUPLICATE OF AN EMAIL RECEIVED FROM INTO THE US AFL QA APUS EMAIL BOX ON 17APR2026. 17APR2026 - A REPORT (B)(4) WAS RECEIVED FROM IN THE PRODUCT COMPLAINTS EMAIL BOX REGARDING IZERVAY. THE INFORMATION CONTAINED IN THE REPORT IS IDENTICAL TO WHAT WAS DOCUMENTED IN (B)(4). THERE IS NO NEW OR ADDITIONAL INFORMATION. 17APR2026 - THE PROVIDED IMW B&S REPLACEMENT FORM INDICATES A PHOTO WAS PROVIDED. AN EMAIL WAS SENT TO RETRIEVE THE PHOTO. 17APR2026 - CALLED THE EYE CLINIC AND LEFT A VOICE MESSAGE REQUESTING A CALL BACK TO GATHER ADDITIONAL DETAILS. 17APR2026 - REFERENCE THE ATTACHED REPORTS REGARDING THE LOT QUERY AND SIMILAR DEFECT QUERY. 17APR2026 - PRELIMINARY AND STANDARD INVESTIGATION REQUESTS SENT TO PCI SD AND BD (SYRINGE AND NEEDLE COMPONENTS). INITIAL IMPACT/RISK: MEDIUM. INITIAL IMPACT/RISK ANALYSIS SUMMARY: NO PORTION OF THE PRODUCT WAS ADMINISTERED TO THE PATIENT. THE PRODUCT POSES NO THREAT TO THE USER WITH REGARD TO THE SAFETY AND FUNCTION OF THE PRODUCT BUT POTENTIALLY IS UNFIT FOR USE AS DETERMINED BY THE INVESTIGATION. CUSTOMER RESPONSE ON 21-APR-2026. FOR (B)(4): 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 04/16/2026. 2. IT WAS MENTIONED AS "PARTICLE OBSERVED IN SYRINGE". COULD YOU PLEASE CONFIRM WHETHER ANY ISSUES WERE OBSERVED WITH THE NEEDLE PRODUCT? THE EYE CLINIC DID NOT REPORT ANY ISSUES WITH NEEDLE. HOWEVER, AN INVESTIGATION IS NEEDED TO RULE OUT ANY ISSUES WITH THE NEEDLE COMPONENT. 3. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN INVESTIGATE FURTHER? IT WAS CONFIRMED THAT THE FIELD SAMPLE IS AVAILABLE FOR RETURN. PLEASE PROVIDE A SHIPPING LABEL. 4. DO YOU HAVE ANY PHOTO SAMPLES AVAILABLE FOR INVESTIGATION? IF YES, COULD YOU KINDLY SHARE THEM? SEE ATTACHED. FOR (B)(4): 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? SEE QUESTION 1 FOR (B)(4). 2. COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR RETURN SO WE CAN INVESTIGATE FURTHER? SEE QUESTION 3 FOR (B)(4). 3. DO YOU HAVE ANY PHOTO SAMPLES AVAILABLE FOR INVESTIGATION? IF YES, COULD YOU KINDLY SHARE THEM? SEE QUESTION 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206523 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3011963 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1