BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C BLOC

    MDR report key: 3770932 · Received April 21, 2014

    Report

    Report Number
    MW5035754
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 18, 2014
    Manufacturer
    KIMBERLY CLARK / IFLOW
    Product Code
    MEB
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT WAS A PORT-A-CATH FOR ONGOING CANCER TREATMENT. AFTER SURGERY, AN ON-Q C-BLOC (MODEL 6007) WAS FILLED WITH ROPIVACAINE 0.2%. OVER THE NIGHT, THE PT BECAME CONFUSED AND DISCONNECTED IV AND ON-Q LINES. WHEN THE NURSE RECONNECTED THE LINE, THE ON-Q WAS INADVERTENTLY CONNECTED TO THE PORT-A-CATH BECAUSE THE LUER-LOCK END IS SIMILAR TO THE IV CONNECTOR. THE PT RECEIVED INTRAVENOUS ROPIVACAINE FOR APPROX 8 HRS BEFORE THE MISTAKE WAS NOTICED. THE ERROR WAS NOTICED BY THE NEXT SHIFT AND CORRECTED. NO HARM TO PT BUT PCA CONDUCTED DUE TO THE POTENTIAL FOR A THREATENING EVENT. AS PART OF THE RCA PROCESS, A RECOMMENDATION WAS MADE TO FILE A MEDWATCH REPORT. WE RECOMMEND THAT THE ON-Q DEVICE SHOULD HAVE A CONNECTOR THAT IS CLEARLY DIFFERENT THAN STANDARD IV TUBING SINCE LOCAL ANESTHETIC INFUSION WITH ON-Q IS NOT INTENDED FOR INTRAVENOUS INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241354 ON-Q C BLOC PORT-A-CATH MEB KIMBERLY CLARK / IFLOW C66007

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention