BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 8 0CM

    MDR report key: 1943992 · Received December 3, 2010

    Report

    Report Number
    2242445-2010-00075
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SCHEDULED FOR A HEMODYNAMIC CONTRAST TEST. AFTER INSERTING THE CATHETER, THE CONTRAST MEDIUM WAS INJECTED (22CC TO 12CC/SEG 540 PSI) AND AT THIS TIME "LIQUID WAS SEEN COMING OUT OF THE CATHETER." THE AI-07135 WAS REMOVED AND ANOTHER CATHETER WAS INSERTED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS LISTED AS FINE.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO