BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL ACCESS TRAY WITH H.025 SPRING-W

    MDR report key: 1884224 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00078
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    March 16, 2009
    Report Date
    March 22, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    KGZ
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL. THIS IS ONE OF 3 RECORDS REFLECTING MULTIPLE OCCURRENCES (B)(4). ADDITIONAL OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00080, MDR #1036844-2010-00077. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM JANUARY 1, 2009 THROUGH JULY 27, 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND (B)(6) REPORTS. PLEASE REFER TO THE MDR FOR THE ORIGINAL COMPLAINT REFERENCED ABOVE FOR THE FOLLOW-UP FOR THIS MDR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE EXTENSION TUBING THAT IS PACKAGED WITH THE STATLOCK HAS COME APART. THE TUBING IS SEPARATING FROM THE STOPCOCK OR THE LUER LOCK CONNECTION. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL ACCESS TRAY WITH H.025 SPRING-W ARTERIAL CATHETER PRODUCTS KGZ ARROW INTERNATIONAL INC RF8123781

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK