BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 22085151 · Received May 26, 2025

    Report

    Report Number
    1911916-2025-00373
    Event Type
    Malfunction
    Date Received
    May 26, 2025
    Date of Event
    May 16, 2025
    Report Date
    June 23, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052005
    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

    (B)(6) FOLLOW UP A REPORT WAS RECEIVED INDICATING THAT THE NEEDLE HAD DETACHED FROM THE SYRINGE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION OF THE PRODUCT COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE SUBMITTED AND REVIEWED BY OUR QUALITY TEAM. ONE IMAGE DEPICTED A NON-BD BRANDED PACKAGING SHELF BOX, WHILE THE OTHER SHOWED A SYRINGE PLACED ON AN OPENED BOX. NO ADDITIONAL INSIGHTS COULD BE DERIVED FROM THE PHOTOGRAPHS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED FOR THE SPECIFIED MATERIAL NUMBER 305200, LOT 2172517. THE REVIEW FOUND NO QUALITY ISSUES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FURTHERMORE, THERE WERE NO ASSOCIATED QUALITY NOTIFICATIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND THE LIMITED PHOTOGRAPHIC EVIDENCE, THE REPORTED ISSUE COULD NOT BE CONFIRMED. IN THE ABSENCE OF THE PHYSICAL SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION. ADDITIONAL INFORMATION RECEIVED, BD PRODUCT REPORTED WAS NOT USED. MFR#: 1911916-2025-00373 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FROM CUSTOMER: IT HAS BEEN CONFIRMED THAT THE NEEDLE THAT CAME OFF THE SYRINGE WAS A 30-GAUGE NEED SUPPLIED BY THE EYE CLINIC AND NOT THE FILTER NEEDLE THAT CAME WITH THE IZERVAY KIT. PLEASE CANCEL THE INVESTIGATION REQUEST FOR THE FILTER NEEDLE ((B)(4)).

    Description of Event or Problem · 0

    MATERIAL#: 305200 BATCH#: 2172517. IT WAS REPORTED BY THE CUSTOMER THAT ¿NEEDLE CAME OFF SYRINGE¿ VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE INITIATE A COMPLAINT INVESTIGATION AND HAVE IT COMPLETED WITHIN 45-60 DAYS REFERENCING XXX RECORD # (B)(6) FOR ¿NEEDLE CAME OFF SYRINGE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331179 NEEDLE FILTER 19X1-1/2 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 2172517 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown