BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE

    MDR report key: 7342148 · Received March 15, 2018

    Report

    Report Number
    3009081593-2018-00014
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 22, 2018
    Report Date
    February 26, 2018
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5239129. MEDICAL DEVICE EXPIRATION DATE: 2019-07-31. DEVICE MANUFACTURE DATE: 2015-08-27. MEDICAL DEVICE LOT #: 5243391. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. DEVICE MANUFACTURE DATE: 2015-08-31. INVESTIGATION: THE CUSTOMER ISSUED A COMPLAINT FOR A SAFETY DEVICE WHICH DID NOT ACTIVATE DETECTED BY END USER. NEITHER SAMPLE NOR PHOTO WAS PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. IT SHOULD BE NOTED THAT TESTS PERFORMED BY BD (B)(4) DURING PRODUCTION CONTROLS ARE RELATED TO THE ASSEMBLED DEVICE, WITHOUT USING SYRINGE AND PLUNGER ROD. TESTING OF COMBINATION PRODUCT IS OUT OF SCOPE FOR SAFETY DEVICE MANUFACTURING. BASED ON INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM ON A BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE FAILED TO ACTIVATE, LEAVING THE NEEDLE EXPOSED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184771 BD ULTRASAFE PASSIVE¿ X-SERIES NEEDLE GUARD SYRINGE SAFETY SYRINGE WITH NEEDLE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other