BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC KIT 2-LUMEN: 5 FR X 21-21/32 IN (55 C

    MDR report key: 2922075 · Received January 15, 2013

    Report

    Report Number
    1036844-2013-00015
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K073451
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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

    THIS EVENT WAS RECEIVED VIA A TELEPHONE CALL FROM THE DISTRIBUTOR. IT WAS REPORTED THE CATHETER WAS INSERTED WITHOUT ISSUE VIA THE UPPER ARM. THE PT WAS TAKEN TO RADIOLOGY AND A LEAK WAS NOTED AT THE INSERTION SITE. WHEN THE CLINICIAN REMOVED THE DRESSING, THEY NOTED THE CATHETER WAS SPLIT ABOVE THE AREA OF THE BOX CLAMP. PRESSURE INJECTION HAD OCCURRED FOR THE CAT SCAN TO BE PERFORMED. THE SPILT WAS OUTSIDE OF THE PT'S BODY. AN OVER THE WIRE EXCHANGE WAS PERFORMED TO REMOVE AND EXCHANGE THE PICC CATHETER. THERE WAS NO DELAY IN TREATMENT, NO PT COMPLICATIONS, INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22330 PICC KIT 2-LUMEN: 5 FR X 21-21/32 IN (55 C PERIPHERALLY INSERTED CENTRAL CATHETERS FOZ ARROW INTERNATIONAL INC RF2108539

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK