BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOK: 400ML, 2-14 ML/HR SELECT-A-FLOW

    MDR report key: 2922341 · Received January 11, 2013

    Report

    Report Number
    2026095-2013-00011
    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
    MEB
    PMA / PMN Number
    K063530
    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: THERE WAS NO LOT INFO PROVIDED FOR THE PUMP. 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: 400 ML; FLOW RATE: 10 ML/HR; PROCEDURE: CATHETER INSERTION; CATHPLACE: CATHETER WAS TUNNELED AT PERI-SPINAL/INTERCOSTAL AREAS. (REFERENCE 2026095-2013-00009/12/-01453 A) (REFERENCE 2026095-2013-00010/12/01453 B). DOCTOR REPORTED A SURGICAL SITE WOULD INFECTION WITH AN ON-Q PUMP. PT HAD MULTIPLE RIB FRACTURES. AN ON-Q SILVERSOAKER CATHETER WAS TUNNELED AT PERI-SPINAL/INTERCOSTAL ARES. IT WAS UNK WHEN THE CATHETER WAS REMOVED. THE PT NEEDED TO BE RETURNED TO THE OPERATING ROOM FOR INCISION NAD DRAINAGE OF THE WOUND. PT IS FINE, NO COMPLICATIONS AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16478 ON-Q C-BLOK: 400ML, 2-14 ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC. CB004 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other