BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ 27 G X 1/2" HYPODERMIC NEEDLES

    MDR report key: 16278928 · Received February 1, 2023

    Report

    Report Number
    1911916-2023-00047
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    December 29, 2022
    Report Date
    January 13, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION, THREE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A PACKAGING BLISTER TOP WEB WITH LOT 9193535. THE SECOND PHOTO SHOWS THE PACKAGING BLISTER BOTTOM WEB SIDE WHERE THE UNITS ARE VISIBLE. THE FINAL PHOTO SHOWS THE PACKAGING BLISTER TOP AND BOTTOMS WEBS WHERE THE LOT NUMBER APPEARS TO BE 6006589. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305109, LOT NUMBER 6006589. 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 COULD NOT BE CONFIRMED, AND 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PRECISIONGLIDE¿ 27 G X 1/2" HYPODERMIC NEEDLES THE LABEL INFORMATION IS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR THE LOT NUMBER 9193535, THIS IS JUST TO SHOW ACTUAL STOCK FROM KSM TO COMPARE WITH THE REPORTED SUSPECTED COUNTERFEIT OR PARALLEL IMPORT PRECISION GLIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347787 BD PRECISIONGLIDE¿ 27 G X 1/2" HYPODERMIC NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305109 6006589 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown