BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 8 0CM

    MDR report key: 1757146 · Received June 18, 2010

    Report

    Report Number
    2242445-2010-00043
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 27, 2010
    Report Date
    June 11, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    A
    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 AFTER THE CATHETER WAS INSERTED, THE USER INJECTED THE CONTRAST AGENT INTO THE CATHETER USING A MEDRAD INC. INJECTOR. IT WAS AT THAT TIME, THE CATHETER RUPTURED BELOW THE JUNCTION HUB. AS A RESULT, THE CATHETER WAS REPLACED. THERE WERE NO REPORTED PATIENT COMPLICATIONS. IT WAS ALSO REPORTED THAT THE PRESSURE THE USER USED WAS AROUND 520PST WHICH IS WITHIN SPECIFICATIONS.

    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 INTERNATIONAL INC MF9120845

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN MEDRAD INC. INJECTOR