BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BLUNT FILL NEEDLE WITH FILTER

    MDR report key: 12107173 · Received July 2, 2021

    Report

    Report Number
    1911916-2021-00630
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903052111
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.INVESTIGATION SUMMARY:IT WAS REPORTED THERE WAS WHITE PAINT-LIKE MATERIALS OUTSIDE OF THE SYRINGE/NEEDLE TIP. TO AID IN THE INVESTIGATION THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW AN EMPTY VIAL. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305211, LOT NUMBER 8250854. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD BLUNT FILL NEEDLE WITH FILTER EXPERIENCED FOREIGN MATTER ON THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EYLEA VIAL ¿ DURING THE CUSTOMER WITHDRAWN THE SOLUTION FROM VIAL TO SYRINGE, FOUND UNKNOWN FOREIGN MATERIAL INTO THE SOLUTION. THERE WAS WHITE PAINT-LIKE MATERIALS OUTSIDE OF THE SYRINGE/ NEEDLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003533 BD BLUNT FILL NEEDLE WITH FILTER MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 305211 8250854 30382903052111

    Patients

    Seq Age Sex Outcome Treatment
    1