BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC KIT: 4 FR X 21-1/2IN (55 CM)

    MDR report key: 3021020 · Received March 20, 2013

    Report

    Report Number
    1036844-2013-00099
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJT
    PMA / PMN Number
    K003006
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN RADIOLOGY, THE PEEL-AWAY SHEATH DID NOT BREAK CLEANLY AT THE TIP RESULTING IN PARTIAL REMOVAL OF THE NEWLY INSERTED CATHETER FROM THE PT'S BASILIC VEIN. HOWEVER, THE USER WAS ABLE TO RE-ADVANCE THE CATHETER TO THE CORRECT POSITION WITHOUT INCIDENT. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116259 PICC KIT: 4 FR X 21-1/2IN (55 CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJT ARROW INTL., INC. RF2107151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK