BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 9875898 · Received March 24, 2020

    Report

    Report Number
    1911916-2020-00298
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    March 16, 2020
    Report Date
    March 17, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLE WAS RECEIVED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN¿T BE DETERMINED AS NO SAMPLES WERE RECEIVED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. 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. THIS IS THE 1ST COMPLAINT FOR LOT # 7100624 FOR THIS TYPE OF DEFECT OR SYMPTOM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DRAWING MEDICATION A FIBROUS PARTICLE WAS DISCOVERED IN SYRINGE WITH A BD BLUNT FILL NEEDLE WITH FILTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT AFTER DRAWING THE SOLUTION THROUGH THE FILTER NEEDLE INTO THE SYRINGE, A FIBROUS PARTICLE WAS DISCOVERED IN THE SYRINGE. NO FILTER NEEDLE AS SAMPLE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339587 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 7200624 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other