BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP

    MDR report key: 9593471 · Received January 15, 2020

    Report

    Report Number
    1911916-2020-00010
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    November 18, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903052110
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RECEIVED IN COLUMBUS; THEREFORE, SAMPLE ANALYSIS COULD NOT BE PERFORMED AND THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. FTIR ANALYSIS PERFORMED AT A FACILITY IN JAPAN NOTED THAT THE (FM) FOREIGN MATTER WAS ALMOST IDENTIFIED AS BUTYL RUBBER. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. THIS IS THE 3RD COMPLAINT FOR LOT # 8173915 FOR THIS TYPE OF DEFECT OR SYMPTOM. PREVIOUS COMPLAINT (B)(4). ROOT CAUSE DESCRIPTION: DURING THE BFN MOLDING AND ASSEMBLY PROCESSES BD DO NOT USE BUTYL RUBBER. IT COULD POSSIBLY BE RESIDUE FROM THE SYRINGE STOPPER. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE FOREIGN MATTER WAS FOUND IN THE SYRINGE WHILE DRAWING UP MEDICATION WITH THE BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN DRAWING THE DRUG, WHITE FM WAS CONFIRMED IN THE SYRINGE. THE FM WAS ALMOST IDENTIFIED AS BUTYL RUBBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57217 BD¿ BLUNT FILTER NEEDLE WITH BLUNT FILL TIP NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173915 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other