BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 21967997 · Received May 6, 2025

    Report

    Report Number
    1911916-2025-00328
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 5, 2025
    Report Date
    May 15, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE USER WAS UNABLE TO SEPARATE THE FILTER NEEDLE FROM THE LUER LOCK SYRINGE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305211 AND LOT NUMBER 2021752. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    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

    EVENT DETAILS: I AM WRITING TO INFORM YOU OF A QUALITY COMPLAINT THAT BAYER RECEIVED RELATED TO THE BD BLUNT FILTER NEEDLE (ITEM 305211, ¿BLUNT FILTER NEEDLE WITH FILTER, 18G X 1 ½ (1.2MM X 40MM, 5 M FILTER)¿. AS BACKGROUND INFORMATION, BAYER IS SPONSORING A CLINICAL STUDY WHERE THE USER HAS TO WITHDRAW (AND FILTER) RECONSTITUTED MEDICATION FROM A VIAL USING 305211. FOLLOWING THIS STEP THE USER MUST BE ABLE TO REMOVE 305211 FROM THE LUER-LOCK SYRINGE IN ORDER TO ATTACH AN ADMINISTRATION NEEDLE AND THEN ADMINISTER THE MEDICATION. IN THE REPORTED COMPLAINT, IT WAS REPORTED THAT FOLLOWING WITHDRAWAL OF THE MEDICATION FROM THE VIAL THROUGH 305211, THE USER (AT A CLINICAL STUDY SITE IN THE USA) WAS UNABLE TO SEPARATE THE FILTER NEEDLE FROM THE LUER LOCK SYRINGE WITHOUT RISKING COMPONENT CONTAMINATION OR INJURY. AS A RESULT, REPLACEMENTS OF THE MEDICATION VIAL, FILTER NEEDLE AND SYRINGE WERE USED AND THE PROCEDURE HAD TO BE REPEATED. ADDITIONAL INFORMATION COULD YOU PLEASE PROVIDE THE EVENT OCCURRENCE DATE OF THE INCIDENT? THIS EVENT OCCURRED 05 APR 2024. WAS THE DEVICE BEING USED IN/ON PATIENT WHEN THE ISSUE OCCURRED? DEVICE WAS USED, BUT DRUG WAS NOT ADMINISTERED TO THE SUBJECT. WAS PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN PATIENT WAS NOT HARMED. WAS THE HCP PRESENT WHEN THE ISSUE OCCURRED? UNKNOWN, COMPLAINANT DID NOT PROVIDE THIS INFORMATION. IF LEAKAGE OCCURRED, PLEASE CONFIRM THE FLUID THAT LEAKED. NO LEAKAGE WAS ADDITIONAL MEDICAL INTERVENTION/MEDICATION REQUIRED? IF YES, PLEASE EXPLAIN ANOTHER DRUG KIT (REPLACEMENT) WAS DISPENSED AND USED ON THE SUBJECT. THE AFFECTED 305211 WAS PART OF BD BATCH: 2021752.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010743 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 2021752 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown