BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASAFE X100L PNG RASPBERRY NVS STEIN

    MDR report key: 9534282 · Received December 31, 2019

    Report

    Report Number
    3009081593-2019-00281
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    November 28, 2019
    Report Date
    January 20, 2020
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 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. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. COMPLAINT IS UNCONFIRMED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG RASPBERRY NVS STEIN EXPERIENCED THE END USER BEING UNABLE TO DETECT THE ACTIVATION OF THE DEVICE AND THE USER UNABLE TO ACTIVATE THE SAFETY GUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE GUARD DID NOT WORK SMOOTHLY. EVEN IF THE PLUNGER HEAD WENT DOWN TO (TOUCHED) THE PART OF NEEDLE-SHIELD RELEASE, THE NEEDLE SHIELD DID NOT EXTEND (A KIND OF STUCK). WHEN THE PLUNGER WAS FULLY PRESSED (HARD), THE NEEDLE SHIELD EXTENDED. DIFFICULT TO ACTIVATE NEEDLE SAFETY DEVICE.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: AN ADDITIONAL PMA/510(K) WAS LISTED AS K122558. 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 · 1

    IT WAS REPORTED THAT THE ULTRASAFE X100L PNG RASPBERRY NVS STEIN EXPERIENCED THE END USER BEING UNABLE TO DETECT THE ACTIVATION OF THE DEVICE AND THE USER UNABLE TO ACTIVATE THE SAFETY GUARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE GUARD DID NOT WORK SMOOTHLY. EVEN IF THE PLUNGER HEAD WENT DOWN TO (TOUCHED) THE PART OF NEEDLE-SHIELD RELEASE, THE NEEDLE SHIELD DID NOT EXTEND (A KIND OF STUCK). WHEN THE PLUNGER WAS FULLY PRESSED (HARD), THE NEEDLE SHIELD EXTENDED. DIFFICULT TO ACTIVATE NEEDLE SAFETY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331699 ULTRASAFE X100L PNG RASPBERRY NVS STEIN PISTON SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) 8117536

    Patients

    Seq Age Sex Outcome Treatment
    1 Other