BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X100L BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 6472426 · Received April 7, 2017

    Report

    Report Number
    3009081593-2017-00005
    Event Type
    Malfunction
    Date Received
    April 7, 2017
    Date of Event
    February 27, 2017
    Report Date
    April 7, 2017
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K011369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. AS PART OF A NO SAMPLE INVESTIGATION, 36 RETENTION SAMPLES WERE EVALUATED FOR SAFETY MECHANISM FAILURE; 10 UNITS WERE TESTED BY ACTIVATION CYCLE AND 26 UNITS WERE TESTED BY MANUAL TRIGGERING. ALL SAMPLES PASSED TESTING, REACHED LOCK-OUT POSITION AFTER ACTIVATION, AND DID NOT SHOW ANY SAFETY DEVICE ISSUES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES OR NON-CONFORMANCES DURING THE MANUFACTURE OF THE REPORTED LOT # 5243391. A MANUFACTURING PROCESS REVIEW SHOWED NO ISSUES WITH SPRING FORMATION, DEVICE ASSEMBLY, PACKAGING, RAW MATERIAL INCOMING INSPECTION, IN PROCESS INSPECTION (100% AUTOMATED PRIMARY FUNCTION TEST, CONTROLLED TRIGGER TEST, ACTIVATION CYCLE TEST), OR FINAL INSPECTION. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. NO ISSUES WERE OBSERVED WITH RETENTION SAMPLE TESTING OR FOUND WITHIN THE DEVICE HISTORY RECORD AND MANUFACTURING PROCESS REVIEWS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A PATIENT HAD INJECTED HERSELF USING A X100L BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE, THE SAFETY MECHANISM FAILED TO FUNCTION PROPERLY. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253239 X100L BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 5243391

    Patients

    Seq Age Sex Outcome Treatment
    1 Other