BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-BLOCKER KIT

    MDR report key: 10444035 · Received August 24, 2020

    Report

    Report Number
    3006425876-2020-00739
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 5, 2020
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CBI
    PMA / PMN Number
    K121462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#1900078655 CORRECTED DATA: SECTION B.1.-'ADVERSE EVENT' SELECTED. SECTION B.2.-'REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE' SELECTED. SECTION H.1.-CORRECTED TO 'SERIOUS INJURY'. SECTION H.6.-PATIENT CODES UPDATED. ADDITIONAL INFORMATION RECEIVED REGARDING THE EVENT. THE CUSTOMER HAS REPORTED THAT THEY OBSERVED INSUFFLATION OF THE NON-DEPENDENT LUNG. IT WAS ALSO REPORTED THAT THERE WAS HIGH PEAK PRESSURE IN COMBINATION WITH DESATURATION (SEVERITY OF DESATURATION UNKNOWN). DAMAGE TO THE LUNG WAS ALSO REPORTED (SURGICAL INCISION IN NON-DEPENDENT LUNG, INFLATED LUNG). INVESTIGATION RESULTS: THE SAMPLE WAS RETURNED AND SENT TO THE MANUFACTURING SITE FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND NO ISSUES WERE DETEC TED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE LOT NUMBER REPORTED AND THERE WERE NO ISSUES FOUND THAT WERE RELATED TO THE REPORTED COMPLAINT. THE RETURNED SAMPLE WAS THEN SENT TO THE SUPPLIER FOR FURTHER INVESTIGATION AND THE SUPPLIER HAS CONFIRMED THE DEFECT. THE SUPPLIER HAS REPORTED THE FOLLOWING ROOT CAUSE IDENTIFICATION: 1. PROCESS CAPABILITY - CROSSOVER BETWEEN LUMENS INSIDE THE CATHETER HUB. 2. INADEQUATE TEST METHOD - THE CURRENT LEAK TESTER DOES NOT DETECT A MICRO LEAK. A NON-CONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT REPORTED AS: "ON AUGUST 3 AN EZB WAS USED WITH A PATIENT PLANNED FOR A THORACOSCOPY WITH TALKAGE. THE EZB WAS TESTED IN ADVANCE BOTH CUFFS WERE INFLATED SEPARATELY AND WERE NOT LEAKED. LAYING ON THE BACK, THE EZB WAS SUBMITTED AND THE CUFF VOLUME WAS DETERMINED. THE RIGHT SIDE BRONCHUS WAS CLOSED (FIBER CONTROLLED) WITH 12ML IN THE YELLOW CUFF AFTER THIS THE CUFF WAS EMPTIED. AFTER REPOSITIONING ON THE SIDE (FIBER CHECKED) THE CUFF WAS INFLATED AGAIN. 9 MIN AFTER, THE SURGERY PUT THE INCISION. HE CUT IN THE RIGHT LUNG , WHICH WAS UNINTENTIONALLY VENTILATED. AT THAT MOMENT WE SAW THAT THE OTHER BLUE CUFF WAS FILLED (3 ML OF AIR WE COULD GET OUT THERE). AFTER RESUMING EVERYTHING (INFLATING YELLOW CUFF AND CHECKING BLUE CUFF), THE BLUE CUFF INFLATED PROGRESSIVELY AGAIN."

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT REPORTED AS: "ON AUGUST 3 AN EZB WAS USED WITH A PATIENT PLANNED FOR A THORACOSCOPY WITH TALKAGE. THE EZB WAS TESTED IN ADVANCE BOTH CUFFS WERE INFLATED SEPARATELY AND WERE NOT LEAKED. LAYING ON THE BACK, THE EZB WAS SUBMITTED AND THE CUFF VOLUME WAS DETERMINED. THE RIGHT SIDE BRONCHUS WAS CLOSED (FIBER CONTROLLED) WITH 12ML IN THE YELLOW CUFF AFTER THIS THE CUFF WAS EMPTIED. AFTER REPOSITIONING ON THE SIDE (FIBER CHECKED) THE CUFF WAS INFLATED AGAIN. 9 MIN AFTER, THE SURGERY PUT THE INCISION. HE CUT IN THE RIGHT LUNG , WHICH WAS UNINTENTIONALLY VENTILATED. AT THAT MOMENT WE SAW THAT THE OTHER BLUE CUFF WAS FILLED (3 ML OF AIR WE COULD GET OUT THERE). AFTER RESUMING EVERYTHING (INFLATING YELLOW CUFF AND CHECKING BLUE CUFF), THE BLUE CUFF INFLATED PROGRESSIVELY AGAIN." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908822 EZ-BLOCKER KIT EZ BLOCKER CBI TELEFLEX MEDICAL IPN913391 71F20E1245

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE REPORTED| NONE REPORTED| NONE REPORTED