BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 SB

    MDR report key: 8693202 · Received June 12, 2019

    Report

    Report Number
    1911916-2019-00581
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    UDI-DI
    30382903051992
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE (1) SAMPLE WAS RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLE WAS EXAMINED VISUALLY USING UNAIDED VISION. THE NEEDLE HAS PIERCED THE NEEDLE SHIELD AND THE POINT IS STICKING OUT OF THE NEEDLE SHIELD. THE NEEDLE SHIELD HAS A BEND TO IT WHICH CAUSED THE NEEDLE TO PIERCE THROUGH THE SHIELD WHEN THE NEEDLE SHIELD WAS PRESSED ON. THIS MISASSEMBLED PART WAS THEN PACKAGED AUTOMATICALLY AND THEREFORE REACHED THE CUSTOMER. 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. 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. CONCLUSION: THE NEEDLE SHIELD HAS A BEND TO IT WHICH CAUSED THE NEEDLE TO PIERCE THROUGH THE SHIELD WHEN THE NEEDLE SHIELD WAS PRESSED ON. THIS MISASSEMBLED PART WAS THEN PACKAGED AUTOMATICALLY AND THEREFORE REACHED THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE SHIELD PENETRATION OCCURRED WITH A NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE STICKING THROUGH CAP CAUSING NEEDLE STICK."

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 NEEDLE SHIELD PENETRATION OCCURRED WITH A NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE STICKING THROUGH CAP CAUSING NEEDLE STICK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487041 NEEDLE 18X1-1/2 SB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY 8117703 30382903051992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other