BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15883020 · Received November 29, 2022

    Report

    Report Number
    1213809-2022-01106
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 3, 2022
    Report Date
    December 10, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES, RETURNED TO MANUFACTURER ON: 30-NOV-2022. INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLES SEEMED TO BE CLOGGED. TO AID IN THE INVESTIGATION, FOUR SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL FOUR SAMPLES EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305916, LOT NUMBER 2003405. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2003405 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN CREATE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. 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.

    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 3 BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING THE VACCINE INJECTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOKE TO PHARMACY TECH AND THEY STATED THAT THEY CANNOT INJECT VACCINE FROM A PREFILLED SYRINGE USING THE NEEDLE. FEELS TO BE CLOGGED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED DURING THE VACCINE INJECTIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SPOKE TO PHARMACY TECH AND THEY STATED THAT THEY CANNOT INJECT VACCINE FROM A PREFILLED SYRINGE USING THE NEEDLE. FEELS TO BE CLOGGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614459 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2003405 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown