BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 17494846 · Received August 9, 2023

    Report

    Report Number
    1911916-2023-00570
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051985
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 14AUG2023. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A BLACK SUBSTANCE FOUND IN THE NEEDLE. TO AID IN THE INVESTIGATION, TWO SAMPLES IN OPENED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND BOTH SAMPLES HAVE EQUIPMENT LUBRICANT AT THE BOTTOM OF THE NEEDLE AND TOP PART OF THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF, AFTER A REPAIR OR MAINTENANCE OF THE CANNULATOR, THE CANNULATOR WHEEL WAS NOT PROPERLY CLEANED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305198, LOT 3024132. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK SUBSTANCE FOUND IN 3 OF THE BD CONVENTIONAL NEEDLES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTS BLACK SUBSTANCE FOUND IN THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK SUBSTANCE FOUND IN 3 OF THE BD CONVENTIONAL NEEDLES. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER REPORTS BLACK SUBSTANCE FOUND IN THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904874 BD CONVENTIONAL NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 3024132 30382903051985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown