BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3894575 · Received May 2, 2014

    Report

    Report Number
    9611710-2014-00074
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 13, 2011
    Report Date
    May 10, 2011
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K96238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. FIVE (5) UNUSED SAMPLES RECEIVED ON (B)(4) 2011 AND TESTED ON (B)(4) 2011. RESULTS FROM THE INVESTIGATION ARE AS FOLLOWS: TWO UNITS OF THE RETURNED PRODUCT WERE CLOSELY EXAMINED FOR STAINS. BLACK STAINS WERE FOUND ADHERED AT THE BEVEL OF THE REINFORCED TUBE AND THE BALLOON CUFF CONSIDERED AS "NOT ACCEPTABLE" AS PER INSPECTION CRITERIA. HAIR IN PACKAGE MEASURING APPROXIMATELY 8 MM LONG ADHERED AT THE MACHINE END OF THE TUBE AND CONSIDERED "NOT ACCEPTABLE" AS PER INSPECTION CRITERIA. TWO UNITS OF THE RETURNED PRODUCTS WERE CLOSELY EXAMINED FOR FOREIGN SUBSTANCE. FOREIGN SUBSTANCE WAS FOUND AT THE SIDE SEAL OF THE PACK AND INSIDE THE POUCH AND CONSIDERED "NOT ACCEPTABLE" AS PER INSPECTION CRITERIA. REVIEW OF ASSEMBLY RECORDS REVEALED NO SIGNS OF ASSOCIATED DEFECTS DETECTED DURING THE 100% INSPECTION AND LIGHT TEST. IN CONCLUSION, COMPLAINT WAS CONFIRMED AS PER RETURNED SAMPLES. RELATED PERSONNEL WILL BE INFORMED AND APPROPRIATE CORRECTIVE ACTION WILL BE TAKEN TO PREVENT FUTURE RECURRENCES OF SIMILAR TYPE OF DEFECTS. NOTE: THIS MDR IS BEING REPORTED AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BY (B)(4) FOR COMPLAINTS RECEIVED FROM 05/01/2011 - 09/30/2013. (B)(4) WILL CONTINUE TO TRACK AND MONITOR SUCH COMPLAINTS ACCORDING TO (B)(4) COMPLAINT HANDLING AND CAPA PROCEDURES.

    Description of Event or Problem · 1

    DETAILS OF THE COMPLAINT: "STAIN ON PRODUCT: 2 PIECES, HAIR IN PACKAGE: 1 PIECE; FOREIGN SUBSTANCE: 2 PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266145 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) 73BTR BTR UNOMEDICAL SDN BHD 61214070 606754R001

    Patients

    Seq Age Sex Outcome Treatment
    1