BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11891539 · Received May 26, 2021

    Report

    Report Number
    1911916-2021-00485
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THERE WAS A HAIR/FIBER ON THE BLACK PART OF THE PLUNGER ON THE SYRINGE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A SMALL SYRINGE WITH A FIBER INSIDE IN THE AREA WHERE THE RUBBER STOPPER IS. THE OTHER PHOTO SHOWS A BOX AND A SYRINGE CONNECTED TO A NEEDLE ASSEMBLY NEXT TO THE BOX. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 9193523. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. EVEN THOUGH THE PHOTO SHOWS A FIBER INSIDE A SYRINGE, IT IS UNKNOWN HOW IT GOT INTO THE SYRINGE. THIS SITE PROVIDES THE NEEDLE ASSEMBLY ONLY. 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. INVESTIGATION CONCLUSION: WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. EVEN DO THE PHOTO SHOWS A FIBER INSIDE A SYRINGE, IT IS UNKNOWN HOW IT GOT INTO THE SYRINGE. THIS SITE PROVIDES THE NEEDLE ASSEMBLY ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/CATHETER OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305106, BATCH NO: 9193523. ON (B)(6) 2021, THE REPORTER REQUESTED REPLACEMENT BECAUSE THERE IS A HAIR/FIBER ON THE BLACK PART OF THE PLUNGER ON THE SYRINGE. THE REPORTER DENIED ANY ADVERSE EVENTS OR MISSED DOSES DUE TO THIS EVENT. FOREIGN MATTER WAS OBSERVED INSIDE THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786881 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9193523

    Patients

    Seq Age Sex Outcome Treatment
    1