BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X5/8 RB

    MDR report key: 10121596 · Received June 4, 2020

    Report

    Report Number
    1911916-2020-00528
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Date of Event
    May 21, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051220
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. (B)(4) INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED FOR EVALUATION. IT SHOWS A NEEDLE ASSEMBLY CONNECTED TO A SYRINGE, THE NEEDLE ASSEMBLY HAS NO NEEDLE, THERE IS ONE LOOSE NEEDLE NEXT TO IT. THE SYMPTOM IS CONFIRMED BASED ON THE PHOTO SAMPLE. 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. INVESTIGATION CONCLUSION: 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. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: THE SYMPTOM IS CONFIRMED. HOWEVER, NO ROOT CAUSE CAN BE DETERMINED AS NO PHYSICAL SAMPLES WERE RECEIVED. RATIONALE: CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 25X5/8 RB SEPARATED FROM THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305122 BATCH NO. 9093865. IT WAS REPORTED THAT HUB WAS LEAKING, AND WHEN SHE PULLED THE NEEDLE OUT OF THE PATIENT'S ARM THE METAL NEEDLE ACTUALLY DISLODGED FROM THE HUB AND STAYED IN THE PATIENT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585635 NEEDLE 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305122 9093865 30382903051220

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other