BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15820333 · Received November 17, 2022

    Report

    Report Number
    1213809-2022-01033
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 16, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?YES. D10: RETURNED TO MANUFACTURER ON: 17-NOV-2022 H6: INVESTIGATION SUMMARY ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, TEN BLUE COLORED EMBEDDED SPECKS WERE OBSERVED. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED TO DETERMINE THE MAKEUP OF THE FOREIGN MATTER. THE RESULTS SHOWED THAT THE FOREIGN MATTER WAS NITRILE GLOVES. POTENTIAL ROOT CAUSE FOR FOREIGN MATTER CANNOT BE DETERMINED AS NITRILE GLOVES MATERIAL IS NOT USED IN THE NEEDLE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2025241. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT BLUE/GREEN FOREIGN MATTER WAS FOUND SPLATTERED INSIDE THE BD SAFETYGLIDE¿ NEEDLE CAP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "250MM GAUGE BY 1 IN THERE IS BLUE SPECS LIKE TOOTHPASTE SUBSTANCE IN THE CAP SPLATTERED INSIDE CASE THAT HOUSES THE NEEDLE... YES THERE IS SOME GREENISH BLUE SUBSTANCE SPLATTERED ON THE INSIDE OF A NEEDLE CAP OF PRODUCT... I WASN¿T SURE WHAT IS ON THE INSIDE OF THE CAP, BUT IT HAS THE COLOR OF TOOTHPASTE BLUE/GREEN. IT WAS SPLATTERED ON THE INSIDE OF A SYRINGE CAP... ¿ WAS THE ISSUE NOTICED PRIOR TO USE? YES ¿ WHAT WAS THE PRODUCT BEING USED FOR, AT THE TIME THE ISSUE WAS NOTICED? VACCINE INJECTION ¿ WAS THERE ANY PATIENT IMPACT/HARM, DUE TO THE REPORTED ISSUE? NO"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLUE/GREEN FOREIGN MATTER WAS FOUND SPLATTERED INSIDE THE BD SAFETYGLIDE¿ NEEDLE CAP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "250MM GAUGE BY 1 IN THERE IS BLUE SPECS LIKE TOOTHPASTE SUBSTANCE IN THE CAP SPLATTERED INSIDE CASE THAT HOUSES THE NEEDLE... YES THERE IS SOME GREENISH BLUE SUBSTANCE SPLATTERED ON THE INSIDE OF A NEEDLE CAP OF PRODUCT... I WASN¿T SURE WHAT IS ON THE INSIDE OF THE CAP, BUT IT HAS THE COLOR OF TOOTHPASTE BLUE/GREEN. IT WAS SPLATTERED ON THE INSIDE OF A SYRINGE CAP... WAS THE ISSUE NOTICED PRIOR TO USE? YES. WHAT WAS THE PRODUCT BEING USED FOR, AT THE TIME THE ISSUE WAS NOTICED? VACCINE INJECTION. WAS THERE ANY PATIENT IMPACT/HARM, DUE TO THE REPORTED ISSUE? NO"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2780479 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2025241 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown