BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRONCHO-CATH ENDOBRONCHIAL TUBE, LEFT SIDED 39FR.

    MDR report key: 118387 · Received September 4, 1997

    Report

    Report Number
    8020889-1997-00032
    Event Type
    Malfunction
    Date Received
    September 4, 1997
    Date of Event
    August 1, 1997
    Report Date
    August 8, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    CBI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIPTION OF COMPLAINT: THE INNER LUMEN OF THE Y-PIECE (CARLENS ADAPTOR) IS TOO NARROW. RETAIN SAMPLE: THE RETAIN SAMPLE CARLENS ADAPTOR WAS EXAMINED AND THE INNER LUMEN WAS FOUND TO BE PARTIALLY OCCLUDED. THE RETAIN SAMPLE CARLENS ADAPTOR IN CONNECTOR PACK ASSEMBLIES 7C002 AND 7C007 WERE EXAMINED AND THE INNER LUMEN WAS FOUND TO BE PARTIALLY OCCLUDED. CLOSER EXAMINATION OF THE RETAIN SAMPLE REVEALED A SMALL FLAP OF EXCESS PLASTIC IN ONE OF THE PORTS WHERE THE SMALLER DIAMETER TUBE JOINS THE CONNECTOR. THIS THIN FLAP IS SECURE AND NOT LOOSE BUT HAS PARTIALLY OCCLUDED THE INNER DIAMETER. THIS EXCESS PLASTIC HAS BEEN TRACED TO A VERY SPECIFIC BASED MOULDING CAMPAIGN. THIS IS A TWO CAVITY MOULD AND "WEAR" ON THE CORE PIN CAUSED INTERNAL FLASH ON THE PROBLEM ORDER. THIS DETERIORATION IN CORE PIN IS CAUSED BY NORMAL "WEAR AND TEAR" AND IS NOT APPARENT OR DETECTABLE ON VISUAL INSPECTION OF THE MOULD. CAUSE: SINCE NO SAMPLE WAS RETURNED AN EXAMINATION OF THE COMPLAINT SAMPLE CANNOT TAKE PLACE. SUMMARY OF ANALYSIS: QUALITY: NO DEATH OR PERMANENT INJURY TO PT REPORTED. NON CONFIRMED: THE REPORTED PROBLEM WAS NOT DETECTED AS NO UNIT WAS RETURNED. JUSTIFIED: THERE IS EVIDENCE TO SUGGEST THAT THE REPORTED PROBLEM OCCURRED IN HOUSE. CORRECTIVE ACTION/COMMENT: (A) THE MOULD IN QUESTION HAS BEEN REPAIRED AND THE TRAINING PROGRAMME HAS BEEN REVISED TO INCLUDE CAREFUL VISUAL INSPECTION OF THE INJECTION MOULDED PARTS SINCE MOULD WEAR OF THIS NATURE IS NOT APPARENT ON THE TOOL ITSELF. (B) A RECALL OF THE ABOVE LOT NUMBER HAS BEEN INITIATED.

    Description of Event or Problem · 1

    COMPLAINT STATED THAT ONE OF THE INNER LUMENS OF 15MM CONNECTORS WERE OCCLUDED WITH SMALL FRAGMENTS. HOWEVER, ON EVALUATION INTERNAL FLASH ON THE CARLENE ADAPTOR WAS FOUND TO BE THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHO-CATH ENDOBRONCHIAL TUBE, LEFT SIDED 39FR. ENDOBRONCHIAL TUBE, LEFT SIDED, 39FR. CBI MALLINCKRODT MEDICAL, INC. NA 1997-03 5258

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO