BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 14 GA X 20 CM

    MDR report key: 1900550 · Received October 29, 2010

    Report

    Report Number
    3006425876-2010-00072
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPRING WIRE GUIDE (SWG) WAS INSERTED WITHOUT ANY PROBLEMS. DURING REMOVAL, THE SWG UNRAVELED, BUT DID NOT BREAK. THE SWG WAS REMOVED AND THE CATHETER REMAINED IN THE PT. ADDITIONAL INFO WAS RECEIVED ON (B)(6) 2010, FROM THE QA ASSISTANT, TELEFLEX (B)(4) THAT THE INSERTION SITE WAS JUGULAR. THERE WERE NO PT COMPLICATIONS OR DELAY IN THERAPY REPORTED. NO INTERVENTION WAS REQUIRED. THE PT OUTCOME IS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 14 GA X 20 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF9121509

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK