BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q TUNNELER 12 INCH (30 CM)

    MDR report key: 2922356 · Received January 11, 2013

    Report

    Report Number
    2026095-2013-00010
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 14, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K063234
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL NOT BE RETURNED FOR EVALUATION AND INVESTIGATION. RESULTS: A DHR PROCESS CANNOT BE PERFORMED WITHOUT A LOT NUMBER. CONCLUSIONS: IT WAS REPORTED THAT THE SAMPLE WILL NOT BE RETURNED, NO FURTHER CONCLUSION CAN BE DRAWN. IF ADDITIONAL INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 0.2%; FILL VOLUME: NA/ FLOW RATE: NA; PROCEDURE: CATHETER INSERTION; CATHPLACE: CATHETER WAS TUNNELED AT PERI-SPINAL/INTERCOSTAL ARES. (B)(4). DOCTOR REPORTED A SURGICAL SITE WOUND INFECTION WITH AN ON-Q PUMP. PT HAD MULTIPLE RIB FRACTURES. AN ON-Q SILERVERSOAKER CATHETER WAS TUNNELED AT PERI-SPINAL/INTERCOSTAL AREAS. IT WAS UNKNOWN WHEN THE CATHETER WAS REMOVED. THE PT NEEDED TO BE RETURNED TO THE OPERATING ROOM FOR INCISION AND DRAINAGE OF THE WOUND. PT IS FINE, NO COMPLICATIONS AT THIS POINT. THE NURSE PRACTITIONER SUPPLIED LOT INFO FOR THE CATHETER AND TUNNELER, BUT THE HOSPITAL'S CENTRAL SUPPLY DEPARTMENT IS UNABLE TO VERIFY THAT THESE ARE THE LOT NUMBERS USED ON THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16398 ON-Q TUNNELER 12 INCH (30 CM) TUNNELER BSO I-FLOW, LLC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other