BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 15058533 · Received July 19, 2022

    Report

    Report Number
    1911916-2022-00359
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    June 20, 2022
    Report Date
    June 24, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051281
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE PULLED OUT OF THE HUB AFTER REMOVING THE SHIELD. TO AID IN THE INVESTIGATION, ONE PHOTO WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS AN OPENED PACKAGING BLISTER, A NEEDLE HUB, PLASTIC SHIELD AND A NEEDLE. THE NEEDLE HUB HAS WHITE EPOXY. FROM THE PHOTO, IT IS NOT CLEAR IF THE EPOXY COVERS AROUND THE ENTIRE NEEDLE, OR IF THERE IS SUFFICIENT EPOXY IN THE NEEDLE HUB. NO OTHER INFORMATION CAN BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305128, LOT NUMBER 1180510. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED, BUT WITHOUT THE PHYSICAL SAMPLE ANALYSIS A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PULLED OUT OF THE HUB AFTER REMOVING THE CAP OF BD PRECISIONGLIDE¿ NEEDLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I PULLED THE CAP OFF A NEEDLE TO USE AND THE NEEDLE FELL RIGHT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240978 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 1180510 00382903051281

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown