BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIMICROBIAL PICC KIT 1 -LUMEN: 4.5 FR X

    MDR report key: 2841908 · Received November 14, 2012

    Report

    Report Number
    1036844-2012-00320
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    LJS
    PMA / PMN Number
    K112896
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A (B)(6) MALE PATIENT. THE CATHETER WAS PLACED INTO THE PATIENT'S LEFT BRACHIAL VEIN. THE CATHETER WAS PLACED WITH COMPLICATION, FLUSHED, AND DRESSED. THE PATIENT STATED THAT HIS EYES WERE STINGING AND THEN STARTED ITCHING ALL OVER. THE NURSE IMMEDIATELY REVIEWED ALLERGIES WITH THE PATIENT TO INCLUDE LATEX, CHLOROHEXIDINE, AND LIDOCAINE. THE PATIENT DENIED ALLERGIES TO ALL OF THOSE. THE PATIENT THEN STATED THAT HIS MOUTH WAS GETTING BIG, AT WHICH TIME A CODE WAS CALLED. THE PATIENTS FACE WAS RED, REMAINED ALERT, AND WAS JUST SAYING "HURRY, I'M NOT FEELING WELL" AND WAS ALSO DIAPHORETIC. A REPORT WAS GIVEN TO THE CODE RESPONDERS. A CHEST X-RAY WAS NOT DONE IN THE CODE SITUATION. THE NURSE CALLED THE CHIEF OF RADIOLOGY AND HE REMOVED THE CATHETER IN THE SHOCK TRAUMA UNIT. IT WAS STATED THAT THERE WAS A RESISTANCE BECAUSE THE PATIENT'S VEINS WERE RESTRICTING. A NUMBER OF LAB TESTS ARE BEING DONE. THE PATIENT WAS INTUBATED AND IS STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTIMICROBIAL PICC KIT 1 -LUMEN: 4.5 FR X PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTL., INC. RF2022253

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention X-RAY| INTUBATED