BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 7 FR X 30 CM

    MDR report key: 3962608 · Received July 15, 2014

    Report

    Report Number
    1036844-2014-00303
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INVOLVED WAS A (B)(6) OBESE CAUCASIAN FEMALE WITH A PAST HISTORY OF HEMICOLECTOMY AND POST-OP WOUND BREAKDOWN, UNDERGOING A RIGHT SUBCLAVIAN VEIN CVC INSERTION FOR TPN. THIS, HER THIRD ADMISSION TO THE ICU, THE DOCTOR USED ULTRASOUND GUIDANCE TO LOCATE THE SUBCLAVIAN VEIN. A 21GA NEEDLE WAS INSERTED INTO THE PATIENT FOR LOCAL ANESTHETIC PRIOR TO THE 18GA NEEDLE WITHOUT DIFFICULTY. THE DOCTOR MADE SEVERAL UNSUCCESSFUL ATTEMPTS TO INSERT THE NEEDLE RESULTING IN THE KINKING OF THE SWG AND HITTING THE CLAVICLE CAUSING THE NEEDLE CANNULA TO BREAK. THE DOCTOR REPORTED NO FORCE WAS USED DURING INSERTION, HOWEVER, AFTER SEVERAL PENETRATIONS THE NEEDLE SNAPPED. AS A RESULT, THE PROCEDURE WAS ABORTED, AND THE PATIENT HAD TO UNDERGO A CUT DOWN PROCEDURE TO REMOVE THE RETAINED CANULA. A DELAY WAS REPORTED, HOWEVER, NO DEATH OR COMPLICATIONS FROM THE DELAY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412770 CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF3052494

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention ULTRASOUND GUIDANCE