BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 2192735 · Received July 20, 2011

    Report

    Report Number
    2242445-2011-00098
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 14, 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
    UK
    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 DURING PRETEST IN THE CATH LAB, A LEAK FROM THE BALLOON WAS NOTICED, AND AS A RESULT, IT WAS NOT USED. A NEW KIT WAS OPENED AND USED WITHOUT ISSUE. A DELAY WAS REPORTED; HOWEVER, THERE WAS NO DEATH OR COMPLICATIONS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CAHTETER PRODUCTS DQO ARROW INTL., INC. MF0052841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN