BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 1883094 · Received October 15, 2010

    Report

    Report Number
    1036844-2010-00319
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "TUBING BROKE APART." ADDITIONAL INFORMATION WAS RECEIVED ON 10/07/2010 FROM THE MD BY THE NURSE CLINICIAN STATING THAT AS THE RN WAS REMOVING THE PA CATHETER FROM THE PERCUTANEOUS SHEATH INTRODUCER (PSI), THE HUB OF THE INTRODUCER SNAPPED OFF, FRACTURING THE CATHETER WHICH PLACED THE PATIENT AT RISK. THE PATIENT STARTED TO BLEED, IMMEDIATELY THE CATHETER WAS REMOVED. AS A RESULT, A NEW CA-09803 WAS SUCCESSFULLY PLACED IN THE PATIENT. THE INSERTION SITE AND THE AMOUNT OF BLOOD LOSS ARE BOTH UNKNOWN PER THE CUSTOMER. FURTHER CLARIFICATION WAS RECEIVED ON 10/13/2010 BY THE MD STATING THAT IT WAS THE HUB THAT CRACKED. THE CATHETER USED IN THIS EVENT WAS A 7FR. EDWARD LIFE SCIENCES SWAN GANZ CATHETER. THE PATIENT OUTCOME IS "FINE." THERE WERE NO PATIENT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO MEDICAL/SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS KGZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN 7FR. EDWARD LIFE SCIENCES SWAN GANZ CATHETER