BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1873333 · Received September 17, 2010

    Report

    Report Number
    1036844-2010-00285
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K061289
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WITH INFECTIOUS BLOOD DISEASES, AIDS AND HEPATITIS WAS HAVING A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE INSERTED IN THE UPPER ARM. THE PT WAS BLEEDING DURING THE PROCEDURE AND BLOOD "THE SIZE OF A CANTALOUPE" FLOWED DOWN THE LARGE BODY DRAPE AND INTO THE CLINICIAN'S SHOES. THE CLINICIAN STATED THE DRAPE DOES NOT ABSORB BLOOD, BUT UNDERSTANDS THAT THE SMALLER FENESTRATED DRAPE IN THE KIT IS ABSORBENT. THE ADHESIVE AROUND THE FENESTRATION OF THE SMALLER DRAPE WAS NOT APPLIED TO THE PT'S SKIN WHICH ALLOWED THE BLOOD TO FLOW UNDER THE FENESTRATION DOWN TO THE LARGER DRAPE AND INTO HER SHOE. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS REPORTED. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH PT BEING LISTED AS OKAY. ADDITIONAL INFO RECEIVED ON 09/03/2010 FROM THE SALES REP STATED THAT THE FENESTRATION WAS PLACED OVER THE INSERTION SITE, BUT THE ADHESIVE WAS NOT USED TO FIX IT TO THE PT'S SKIN. THE PT APPARENTLY WAS COMBATIVE AND HAD BAD SKIN MAKING IT A VERY DIFFICULT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC KIT 2-LUMEN: 5 FR X 21-21/32IN (55 PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK