BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 8.5FR X 16CM

    MDR report key: 2820255 · Received October 31, 2012

    Report

    Report Number
    3006425876-2012-00114
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    May 29, 2012
    Report Date
    October 31, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE USER NOTICED A PUNCTURE ON THE CATHETERS LUMEN INVOLVING IT'S REPLACEMENT. FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2012, STATES THIS EVENT OCCURRED IN THE CARDIAC INSUFFICIENCY TREATMENT UNIT. THE USER NOTICED THE PERFORATION ON THE EXTENSION LINE 24 HOURS AFTER THE PLACEMENT OF THE CATHETER. THERE WAS NO DELAY IN TREATMENT AND THE PATIENT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 8.5FR X 16CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF2028237

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR