BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOC: 400ML, 2-14 ML/HR, SAF

    MDR report key: 3678928 · Received February 20, 2014

    Report

    Report Number
    2026095-2014-00020
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    January 25, 2014
    Report Date
    January 25, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE DEVICE AS RETURNED TO THE MFR FOR AN INVESTIGATION AND EVALUATION. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED UNIT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE REPORTED LOT NUMBER. RESULTS: AT THIS TIME THE RESULTS ARE PENDING COMPLETION OF THE EVALUATION AND INVESTIGATION WHICH IS CURRENTLY IN PROCESS. PER THE DHR REVIEW THE LOT MEET ALL MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: A CONCLUSION IS NOT YET AVAILABLE AS THE INVESTIGATION AND EVALUATION OF THE PRODUCT IS STILL IN PROGRESS, AND HAS NOT BEEN COMPLETED. AT THE TIME OF THIS REPORT, PER THE REPORTED INFORMATION RECEIVED A PRODUCT MALFUNCTION CANNOT BE RULED OUT. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.2 % ROPIVACAINE. FILL VOLUME: 550 ML. FLOW RATE: 6 ML/HR. PROCEDURE: ROTATOR CUFF REPAIR. CATHPLACE: INTERSCALENE BLOCK. THE PT CONTACTED THE PRODUCT SUPPORT LINE TO REPORT SHE HAD DIFFICULTY SWALLOWING AND DID NOT KNOW IF THE SYMPTOMS WERE CAUSED BY THE ON-Q PUMP OR THE HYDROCODONE. PT MENTIONED THAT SHE RECEIVED A NERVE BLOCK FOR HER SHOULDER SURGERY ON ((B)(6) 2014). THE HOTLINE NURSE ADVISED THE PT THAT HER SYMPTOM COULD NOT IDENTIFY THE MEDICATION LABEL ON THE PUMP. PT WAS ADVISED TO CLAMP THE TUBING OF THE PUMP AND TO CALL THE ANESTHESIOLOGIST ON CALL TO REPORT HER SYMPTOM. AFTER AN HOUR THE HOTLINE NURSE CALLED THE PT BACK TO FOLLOW UP. THE PT HAD SPOKEN TO THE ANESTHESIOLOGIST ON CALL AND HE TOLD HER TO REMOVE THE PUMP AND CATHETER IMMEDIATELY. PT REMOVED THE CATHETER WITHOUT DIFFICULTY. THE PT COULD NOT RECALL THE ANESTHESIOLOGIST'S NAME. THE PT REPORTED THE SWALLOWING WAS ALREADY BECOMING EASIER AND SHE NOTICED A DIFFERENCE SINCE SHE REMOVED THE CATHETER. THE HOTLINE NURSE EXPLAINED TO HER THAT SINCE SHE HAD A REACTION RELATED TO THE ON-Q WE WOULD NEED THE PUMP AND CATHETER TO BE RETURNED FOR EVALUATION. SHE UNDERSTOOD AND AGREED TO SEND BOTH ACK. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014: CONTACTED THE PT AND SHE REPORTED SHE HAS BEEN DOING WELL. THE SYMPTOMS OF HAVING DIFFICULTY SWALLOWING CAME 2 DAYS AFTER THE INFUSION HAS STARED. SHE SPOKE WITH THE ANESTHESIOLOGIST AND TOLD TO REMOVE THE PUMP AND CATHETER. HER SYMPTOMS SUBSIDED AFTER 2 HOURS AFTER THE INFUSION STOPPED. THE PUMP STILL CONTAINED MEDICATION WHEN IT WAS REMOVED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014: CONTACTED THE ANESTHESIOLOGIST DEPARTMENT CHIEF, THEY WERE AWARE OF THE INCIDENT AND THEY DID NOT THINK THAT THERE WERE ANY PRODUCT ISSUES INVOLVED BUT A COMMON EFFECT OF THE BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107764 ON-Q C-BLOC: 400ML, 2-14 ML/HR, SAF ELASTOMERIC PUMP MEB I-FLOW LLC CB004 0201178866

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other HYDROCODONE (DOSAGE NOT PROVIDED)