BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7237640 · Received February 2, 2018

    Report

    Report Number
    8041187-2018-00011
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Date of Event
    January 8, 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 RESULTS: SAMPLE INVESTIGATION ¿ ONE SAMPLE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT SAMPLE WAS OBSERVED WITH DRIED BLOOD. THE SAMPLE WAS STERILIZED. A LEAKAGE TEST WAS PERFORMED WITH NO ABNORMALITY FOUND. ACCORDING TO THE RETURNED INFORMATION, THE COMPLAINT FAILURE SPECIFIES SEPTUM LEAKAGE. FROM STATISTICS DATA, SEPTUM LEAKAGE COMPLAINT RATE IS LOWER THAN THE UPPER LIMIT R&D SPECIFIES. A DHR WAS PERFORMED ON LOT 7142454 WITH NO ABNORMALITIES FOUND IN THE INCOMING MATERIAL, THE WHOLE ASSEMBLY AND PACKING PROCESS. THE PRODUCT WAS FOUND WITHIN SPECIFICATION. THE COMPLAINT IS UNCONFIRMED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S FAILURE MODE. IN CONCLUSION, BECAUSE NO ABNORMALITY WAS FOUND IN THE RETURNED SAMPLE. BD CANNOT FINALIZE THE ROOT CAUSE FOR THE COMPLAINT FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE FOUND BLOOD AND SALINE LEAKAGE ON THE HUB OF A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM AFTER THE PUNCTURING PROCESS. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83005 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 7142454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other