BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVER SOAKER CATHETER

    MDR report key: 2890540 · Received December 14, 2012

    Report

    Report Number
    2026095-2012-00314
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    I-FLOW LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD; ACTUAL DEVICE INVOLVED IN INCIDENT HAS BEEN RETURNED FOR EVALUATION AND INVESTIGATION. THE DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE. THE DIRECTIONS FOR USE (DFU) (1307112, REV. A) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. THE DIRECTIONS FOR USE STATES, "IF RESISTANCE IS ENCOUNTERED OR CATHETER STRETCHES, STOP. CONTINUED PULLING COULD BREAK THE CATHETER. IT'S ADVISABLE TO WAIT 30 TO 60 MINUTES AND TRY AGAIN. THE PATIENT'S BODY MOVEMENTS MAY RELIEVE THE CATHETER TO ALLOW EASIER REMOVAL. DO NOT CUT OR FORCEFULLY REMOVE THE CATHETER. IT ALSO CONTAINS A CAUTION OF "DO NOT CUT OR FORCEFULLY REMOVE CATHETER." I-FLOW HAS ALSO PREPARED A TECHNICAL BULLETIN (1303971, REV. B) IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS OF PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM."

    Description of Event or Problem · 1

    DRUG/DILUENT: NA. FILL VOLUME: NA. FLOW RATE: NA. PROCEDURE: RIB FRACTURE. CATHPLACE: POSTERIOR- PARASPINOUS MUSCLE- 2-3 INCHES LATERAL TO THE SPINE. THE ANESTHESIOLOGIST RECEIVED A PHONE CALL FOR THE TRAUMA STEP DOWN UNIT ON (B)(6) 2012 AT 9:30PM. IT WAS REPORTED THAT A CATHETER HAD "SNAPPED/BROKE" ON THE FLOOR. TWO CATHETERS WERE PLACED ON (B)(6) 2012 IN THE PM, FOR A PATIENT WITH MULTIPLE RIB FRACTURES. THE CATHETERS WERE REMOVED ON (B)(6) 2012 AT 9 PM. THE LEFT CATHETER WAS REMOVED WITHOUT INCIDENT BY THE PATIENT'S NURSE. THE CHARGE NURSE WAS CALLED INTO THE ROOM AFTER THE PATIENT'S NURSE WAS UNABLE TO REMOVE THE RIGHT CATHETER. THE CHARGE NURSE BROKE THE CATHETER UPON REMOVAL FROM THE PATIENT. IT WAS REPORTED THAT THE CHARGE NURSE CALLED THE TRAUMA NP AFTER SHE MET RESISTANCE AND SHE REPORTED THAT THE TRAUMA NP INSTRUCTED HER TO PULL HARDER AFTER SHE WAS UNSUCCESSFUL WITH HER FIRST ATTEMPT AT REMOVING THE RIGHT CATHETER. IT WAS REPORTED SHE PULLED "WITH ALL HER MIGHT" AND THEN THE CATHETER SNAPPED. NEITHER THE CHARGE NURSE NOR THE PATIENT'S NURSE COULD SEE THE CATHETER OR COULD PALPITATE THE CATHETER UNDER THE SKIN AFTER IT BROKE. THEY STATED THERE WAS NO BLEEDING. IT WAS LATER REPORTED ON (B)(6) 2012 THAT AS IT STOOD ON (B)(6) 2012, THE PATIENT WAS STILL IN THE HOSPITAL BEING MONITORED HAVING SUSTAINED MULTIPLE INJURIES FROM HER MOTOR VEHICLE ACCIDENT (MVA) AND HAVING HAD MULTIPLE SURGERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVER SOAKER CATHETER CATHETER BSO I-FLOW LLC PM050-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other