BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BD LUER-LOK¿ BLUNT FILL NEEDLE

    MDR report key: 7059780 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00301
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 11, 2017
    Report Date
    January 30, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050605
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DHR REVIEW FOR BATCH 7192503 (P/N 305060) WAS PERFORMED WITH THE FOLLOWING RESULTS. MANUFACTURING DATE: 7/12/2017 ¿ 7/14/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7192503 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. CONCLUSION: CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 10/20/2017 VIA MEDWATCH # (B)(4). 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 · 1

    IT WAS REPORTED THAT MEDICATION LEAKED BEHIND THE STOPPER ON A BD¿ BD LUER-LOK¿ BLUNT FILL NEEDLE DURING USE. MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840744 BD¿ BD LUER-LOK¿ BLUNT FILL NEEDLE HYPODERMIC SYRINGE W/ NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7192503 30382903050605

    Patients

    Seq Age Sex Outcome Treatment
    1 Other