BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7237661 · Received February 2, 2018

    Report

    Report Number
    8041187-2018-00010
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 9, 2018
    Report Date
    January 16, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT: NO ACTUAL SAMPLE WAS PROVIDED FOR INVESTIGATION. HOWEVER, A PHOTO WAS RECEIVED FOR INVESTIGATION. FOREIGN MATTER WAS OBSERVED AT THE PRN OF THE SAMPLE IN THE PROVIDED PHOTO. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7110499. NO ROOT CAUSE CAN BE DETERMINED AS SAMPLE WAS NOT RETURNED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, PRIOR TO TESTING, THE RUBBER CAP WAS FOUND WITH A ¿DARK COLORED¿ POINT. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82391 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7110499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other