BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUS X100L PNG CLEAR

    MDR report key: 9361575 · Received November 22, 2019

    Report

    Report Number
    3009081593-2019-00263
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 5, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K123743
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9069756, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-10. MEDICAL DEVICE LOT #: 9081800, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-22." INITIAL REPORTER PHONE #: UNKNOWN. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR PRE-ACTIVATED DEVICE 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. 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. DURING THE YEARS OF INVESTIGATION OF COMPLAINTS ABOUT PRE-ACTIVATED DEVICES SEVERAL ROOT CAUSES WERE DISCOVERED WHICH WERE WITHIN THE CUSTOMER¿S SPHERE OF INFLUENCE. BEST PRACTICES AND GUIDELINES WERE COLLECTED AND SUMMARIZED IN STAN-010. RATIONALE: COMPLAINT IS UNCONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE THERE WAS PRE-ACTIVATION AND LEAKAGE OCCURRED WITH A BD ULTRASAFE¿ PLUS X100L PNG CLEAR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE NURSE OPENED THE BLISTER TO PERFORM THE INJECTION, THE PISTON HAD BEEN AUTOMATICALLY ACTIVATED. THEREFORE THE LIQUID CAME OUT FROM THE SYRINGE, NO ADMINISTRATION WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161023 BD ULTRASAFE PLUS X100L PNG CLEAR SYRINGE, ANTISTICK MEG BECTON DICKINSON HUNGARY KFT (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other