BEUDAMED
    FDA Adverse Event Other Summary report: N

    MODIFIED BRONCHO-CATH ENDOBRONCHIAL TUBE LEFT 39FR

    MDR report key: 116690 · Received August 30, 1997

    Report

    Report Number
    9681384-1997-00096
    Event Type
    Other
    Date Received
    August 30, 1997
    Date of Event
    July 30, 1997
    Report Date
    August 29, 1997
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF COMPLAINT: LOOKS LIKE A TEAR OR DEFECT IN CUFF. BATCH PAPERWORK: BATCH AND COMPLAINT RECORDS INDICATED NO SUCH PROLEM WITH THIS ORDER. RETAIN SAMPLE: THE TRACHEAL AND BRONCHIAL CUFF WERE INFLATED AND IMMERSED IN ALCOHOL AND WATER - NO LEAKAGE WAS DETECTED. CAUSE; SINCE NO UNIT WAS RETURNED A COMPREHENSIVE INVESTIGATION CANNOT TAKE PLACE INTO THE CAUSE OF THE COMPLAINT. SUMMARY OF ANALYSIS: QUALITY: THE COMPLAINT UNIT DID NOT CAUSE INJURY TO THE PT. NON CONFIRMED: THE RPT'D PROBLEM WAS NOT VERIFIED AS THE COMPLAINT UNIT WAS NOT RETURNED. NON JUSTIFIED: THERE IS NO EVIDENCE TO SUGGEST THAT THE RPT'D PROBLEM OCCURRED IN HOUSE. CORRECTIVE ACTION/COMMENT: ALL CO CUFFED CATHETERS UNDERGO A FOUR HOUR INFLATE/DEFLATE TEST PRIOR TO PACKING AND IT IS AT THIS POINT THAT ANY DEFECTS ARE REMOVED FROM THE ORDER. OPERATORS ARE AWARE OF THE DELICATE NATURE OF THE CUFFS AND HANDLE THE PRODUCT WITH GREAT CARE THROUGHOUT THE PRODUCTION PROCESS. PRODUCTION COMMENTS: NA.

    Description of Event or Problem · 1

    HOSP REPORTED "CUFF DID NO INFLATE-PILOT BALLOON, LOOKS LIKE A TEAR OR DEFECT IN CUFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODIFIED BRONCHO-CATH ENDOBRONCHIAL TUBE LEFT 39FR BRONCHO-CATH CBI MALLINCKRODT MEDICAL 95894 1997-02-5075

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other