BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RA CATH SET: 22 GA X 1-3/8

    MDR report key: 2133444 · Received June 15, 2011

    Report

    Report Number
    9680794-2011-00038
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 15, 2011
    Manufacturer
    ARROW INTERNACIONAL INC
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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 WHEN THE MD WAS INSERTING THE CATHETER, HE FOUND IT DIFFICULT TO INSERT OVER THE NEEDLE. WHEN HE TRIED TO REMOVE THE NEEDLE WITH THE CATHETER HE NOTICED THAT THE CATHETER WAS MISSING. A SURGEON HAD TO REMOVE THE MISSING PART MAKING A SMALL INCISION TO RETRIEVE THE CATHETER. THERE WAS NO PATIENT DEATH, INJURIES OR COMPLICATIONS NOTED. THERE WAS A DELAY WHILE THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CATHETER SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA CATH SET: 22 GA X 1-3/8 RADIAL ARTERY PRODUCTS DQX ARROW INTERNACIONAL INC CF8123883

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention