BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOBRIGHT CONTINUOUS TRAY WITH 3.5INCH NEEDLE

    MDR report key: 4255563 · Received November 10, 2014

    Report

    Report Number
    2026095-2014-00244
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    HALYARD-IRVINE
    Product Code
    CAZ
    PMA / PMN Number
    K111355
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE EVALUATION OF THE DEVICE IS NOT AVAILABLE AS THE DEVICE IS REPORTED AS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. A USE REVIEW AND A REVIEW OF THE INSTRUCTION S FOR USE (IFU) FOR THE MODEL NUMBER WAS CONDUCTED. RESULTS: AS THE DEVICE AND LOT NUMBER WERE UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE CONDUCTED. THE IFU FOR EPIMED PAIN MANAGEMENT SPIROL EPIDURAL CATHETER PRODUCTS (PI-009) REV. 0) INSTRUCTS USERS TO CONSULT STANDARD TEXTBOOKS AND MEDICAL LITERATURE FOR SPECIFIC TECHNIQUES, PRECAUTIONS AND CONTRAINDICATIONS. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO HALYARD FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINED THE CAUSE FOR THE REPORTED EVENT. AS THE T-BLOC CATHETER WAS USED FOR INTERSCALENE BLOCK POST-SHOULDER SURGERY FOR A PATIENT WITH COPD, THE DEVICE WAS NOT USED PER RECOMMENDATIONS OF THE IFU OR TEXTBOOK RECOMMENDATIONS; HOWEVER IT IS ULTIMATELY UP TO THE PROVIDER TO DETERMINE WHETHER THE PROCEDURE IS APPROPRIATE FOR HIS OR HER PATIENT. IF ADDITIONAL INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, HALYARD WILL SUBMIT A F/U REPORT. INFO FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    PROCEDURE: SHOULDER SURGERY FOR A ROTATOR CUFF REPAIR, CATH PLACE: INTERSCALENE BLOCK. REPORT 2 OF 2; REFERENCE: 2026095-2014-00228/14-00921. IT WAS REPORTED BY A CONSUMER THAT A PATIENT EXPERIENCED PNEUMONIA DURING USE OF DEVICES FROM A T-BLOC TRAY FOR AN INTERSCALENE BLOCK 12 HOURS AFTER SHOULDER SURGERY. THE PATIENT REPORTED SYMPTOMS OF FEELING JITTERY, HAVING SHORTNESS OF BREATH, BURNING IN THE STOMACH AND NAUSEA. THE PUMP WAS CLAMPED AND THE PATIENT WENT TO THE EMERGENCY ROOM. THE PATIENT WAS HOSPITALIZED. THE PATIENT WAS TREATED FOR PNEUMONIA WITH ANTIBIOTICS, NEBULIZER BREATHING TREATMENTS EVERY 4 HOURS, AND ALBUTEROL WAS SWITCHED TO ANOTHER UNK INHALER. THE DEVICE WAS LATER UNCLAMPED AND THE PATIENT CONTINUED TO USE THE PUMP UNTIL THE INFUSION ENDED 2-3 DAYS AFTER SURGERY. THE PATIENT LATER REPORTED THAT SHE WAS FEELING BETTER AND RECOVERING FROM PNEUMONIA. THE DEVICE WAS REPORTED AS UNAVAILABLE FOR RETURN AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723248 ECHOBRIGHT CONTINUOUS TRAY WITH 3.5INCH NEEDLE ANESTHESIA CONDUCTION KIT CAZ HALYARD-IRVINE TBT01089T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R PUMP, CB004 SAF ON-Q -| DRUG: NAROPIN 0.2% -