BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7534523 · Received May 22, 2018

    Report

    Report Number
    1911916-2018-00262
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 18, 2018
    Report Date
    June 27, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A PHOTO WAS RECEIVED FOR EVALUATION HOWEVER VISUALIZATION OF THE PHOTO DOES NOT ALLOW FOR CONFIRMATION OF THE REPORTED FAILURE MODE. BASED ON THE DESCRIPTION PROVIDED, IT APPEARS LIKE THE NEEDLE DEVELOPED AN OBSTRUCTED INNER DIAMETER WHILE BEING USED. PER THE DEVICE HISTORY REVIEW, THERE WERE NO ISSUES OR DEFECTS WITH CLOGGED NEEDLES DURING ASSEMBLY. 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. ASSEMBLY BATCH 6090856 HAD 50 VISUAL INSPECTIONS PERFORMED ON 2,650 PARTS WITH ZERO DEFECTS NOTED. THE ID INSPECTION SYSTEM WAS CHALLENGED 24 TIMES USING 600 PARTS WITH ZERO FAILURES RECORDED. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. INVESTIGATION CONCLUSION: BASED ON THE DESCRIPTION PROVIDED, IT APPEARS LIKE THE NEEDLE DEVELOPED AN OBSTRUCTED INNER DIAMETER WHILE BEING USED. PER THE DEVICE HISTORY REVIEW, THERE WERE NO ISSUES OR DEFECTS WITH CLOGGED NEEDLES DURING ASSEMBLY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WITH THE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH A BROKEN NEEDLE. IT WAS STATED ¿THE CONSUMER HAS HAD ISSUES WITH HIS ENBREL INJECTIONS. HE STATES WHEN HE INJECTED, HE PUSHED DOWN ON PLUNGER, BUT TOWARDS THE END OF THE INJECTION THE NEEDLE PART STAYED IN THE LEG AND THE PLUNGER PART PUSHED BACK AGAINST THE PATIENT AS HE PUSHED THE PLUNGER UNTIL IT POPPED OUT OF THE NEEDLE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378214 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6239515 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other