BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 8 0CM

    MDR report key: 1003421 · Received February 21, 2008

    Report

    Report Number
    2242445-2008-00003
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 21, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, BY THE CLINICIAN, WHEN INJECTING THE CONTRAST MEDIUM INTO THE CATHETER, THE CATHETER BURST APPROX 70CM FROM THE CATHETER TIP. AFTER THIS OCCURRENCE, THE CATHETER WAS EXCHANGED. THE CLINICIAN REPORTED THE CONTRAST WAS INJECTED WITHIN THE SPECIFICATION OF 12ML/ SEC. THERE WERE NO REPORTED PT COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 5 FR 8 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF7054882

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention