BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1 RB

    MDR report key: 20224143 · Received September 16, 2024

    Report

    Report Number
    1911916-2024-00666
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 28, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS FOREIGN MATTER ON THE END OF THE NEEDLE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE NEEDLE HAS AN EPOXY DRIP OVER AT THE NEEDLE TIP. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305195, LOT 4040631. 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. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305195. BATCH NUMBER#: 4040631. IT WAS REPORTED BY CUSTOMER THAT FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL RCC RECEIVED A COMPLAINT VIA PHONE. REF 305195. LOT: 4040631. ISSUE: FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL. DOE: (B)(6) 2024 AND (B)(6) 2024. NO PT HARM FOUND BEFORE INJECTION. SAMPLE IS AVAILABLE. SAMPLE RETURN KIT REQUESTED PLEASE.

    Description of Event or Problem · 0

    MATERIAL#: 305195 BATCH NUMBER#: 4040631 IT WAS REPORTED BY CUSTOMER THAT FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL. RCC RECEIVED A COMPLAINT VIA PHONE. PIR ATTACHED. REF 305195 LOT: 4040631 ISSUE: FM FOUND ON THE END OF THE NEEDLE. WHITE MATERIAL DOE: (B)(6)2024 NO PT HARM FOUND BEFORE INJECTION SAMPLE IS AVAILABLE SAMPLE RETURN KIT REQUESTED, PLEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114579 NEEDLE 18X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4040631 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown