BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 23341585 · Received October 20, 2025

    Report

    Report Number
    1911916-2025-00686
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 4, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE REPORTED INVOLVED THE PRESENCE OF TWO BLACK DOTS ON THE NEEDLE. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS A NEEDLE ASSEMBLY WITHOUT A PLASTIC SHIELD OR PACKAGING, SHOWING TWO DARK-COLORED SPECKS ON THE NEEDLE. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED FOR MATERIAL NUMBER 305211, COVERING POTENTIAL LOT NUMBERS 3181375, 4064627, AND 2341532. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE MANUFACTURING PROCESSES OF THESE LOTS THAT COULD BE LINKED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PROVIDED PHOTOGRAPH, THE REPORTED CONDITION WAS CONFIRMED. HOWEVER, DUE TO THE ABSENCE OF A PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE FILTER BLUNT FILL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO BLACK DOTS APPEARED ON THE PRODUCT(NEEDLE FILTER BLUNT FILL 18*1-1/2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2284224 BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown