BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRONCHO-CATH ENDOBRONCHEAL TUBE, LEFT SIDED, 39FR.

    MDR report key: 87541 · Received April 22, 1997

    Report

    Report Number
    9681384-1997-00039
    Event Type
    Other
    Date Received
    April 22, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 18, 1997
    Manufacturer
    MALLINCKRODT MEDICAL INC.
    Product Code
    CBI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: EVAL PERFORMED ON RETAIN SAMPLES. REFERENCE REPORTING SITE INTERNAL FILE NUMBER MX970260. DESCRIPTION OF COMPLAINT: INFLATION FAILURE. BATCH PAPERWORK: BATCH AND COMPLAINT RECORDS INDICATED NO SUCH PROBLEM 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 COMPLAINANT UNIT DID NOT CAUSE INJURY TO THE PT. NON CONFIRMED: THE REPORTED PROBLEM WAS NOT DETECTED AS THE COMPLAINANT UNIT WAS NOT RETURNED. NON JUSTIFIED: THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED PROBLEM OCCURRED IN HOUSE. CORRECTIVE ACTION/COMMENT: ALL OUR CUFFED CATHETERS UNDERGO A FOUR HR 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.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT CUFF DID NOT REMAIN INFLATED. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHO-CATH ENDOBRONCHEAL TUBE, LEFT SIDED, 39FR. ENDOBROCHIAL TUBE, LEFT SIDED, 39FR. CBI MALLINCKRODT MEDICAL INC. NA 1997-01-4715

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other