BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 8 0CM

    MDR report key: 2150525 · Received June 22, 2011

    Report

    Report Number
    2242445-2011-00082
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 EVENT OCCURRED IN THE CATH LAB. A DYE WAS INJECTED INTO THE CATHETER TWICE; 9 ML/SEC AT 400 PSI FOR THE FIRST INJECTION AND 12 ML/SEC AT 504 PSI FOR THE SECOND INJECTION. THE SECOND DYE INJECTION WENT FINE, BUT ALMOST AT THE SAME TIME A PORTION OF THE CATHETER WHICH WAS OUT OF THE PATIENT'S BODY BURST. AS A RESULT, THE DEVICE WAS REMOVED AND NOT REPLACED SINCE THE PROCEDURE WAS FINISHED AFTER THE SECOND DYE INJECTION. THEREFORE, NO DELAY IN THERAPY. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT'S OUTCOME IS GOOD.

    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. MF0094860

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN