BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUOUS NERVE BLOCK K IT

    MDR report key: 1392649 · Received May 21, 2009

    Report

    Report Number
    1036844-2009-00117
    Event Type
    Injury
    Date Received
    May 21, 2009
    Date of Event
    May 6, 2009
    Report Date
    May 21, 2009
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K021567
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MD WAS USING THE DEVICE IN THE PROCEDURE WHEN THE SALES REPRESENTATIVE RECEIVED A CALL FROM THE ON-Q REP (ON-Q PAINBUSTER POST-OP PAIN RELIEF SYSTEM). IT WAS REPORTED TO THE SALES REP THAT THERE WAS A LEAK ON THE SIDE OF THE CATHETER ABOVE INSERTION SITE. THE ON-Q ALSO ASKED IF MD WAS ALLOWED TO CUT THE CATHETER AND SALES REP STATED "NO". THE SALES REP WAS TOLD AFTER PROCEDURE THAT THE CATHETER WAS IN FACT CUT BY MD AND THAT IT UNRAVELED. THEY HAD DIFFICULTY REMOVING THE REST OF THE CATHETER BUT ALL WAS REMOVED. THE SALES REP ASKED THAT THE CATHETER BE SAVED AND WHEN HE WENT INTO THE HOSPITAL TO GATHER MORE DETAILS AND SAMPLE, IT WAS MISSING. THE SURGERY MATERIALS DIRECTOR TOLD SALES REP THAT IT WAS LEFT AT HIS DOOR, BUT NOW IS MISSING. THE SALES REP EXAMINED THE INTERNAL HOSPITAL REPORT WHICH STATES THE ISSUE WITH THE LEAKING CATHETER, BUT IT DOES NOT SAY THAT CATHETER WAS CUT BY MD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS NERVE BLOCK K IT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK