BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX NEONATAL/PEDIATRIC TRACHEAL INTIBUATION KIT

    MDR report key: 4200954 · Received September 15, 2014

    Report

    Report Number
    2183502-2014-00675
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    November 26, 2013
    Report Date
    September 12, 2014
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL LTD.
    Product Code
    BTR
    PMA / PMN Number
    K790312
    Removal / Correction Number
    9610530-07/03/14-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: NO SAMPLE DEVICE WAS RECEIVED FOR INVESTIGATION. HOWEVER, SMITHS MEDICAL'S INVESTIGATION OF SIMILAR ISSUES HAS IDENTIFIED THAT A NEW TOOL, COMMISSIONED IN (B)(4) 2011, MAY HAVE ALLOWED FOR VARIATION IN FASTENER/CYLINDER DIMENSIONS DURING PRODUCTION. USE OF A BORE GAUGE HAS BEEN ADDED TO THE PRODUCTION PROCESS TO CONFIRM THE INNER DIAMETER OF THE TRACHEAL TUBE WHEN LOCKED WITH THE HOLDER. THIS TEST WILL ALSO CONFIRM THE FASTENER'S INNER DIAMETER AND ITS ABILITY TO PROPERLY ASSEMBLE TO THE TUBE AND HOLDER. PRODUCTION WITH THE NEW MOLD TOOL HAS CEASED AND PRODUCTION WITH THE PREVIOUS MOLD TOOL (PRE (B)(4) 2011) HAS RE-COMMENCED. SMITHS MEDICAL RECALLED SPECIFIC LOTS FOR THIS ISSUE ON 07/10/2014.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THEY EXPERIENCED DIFFICULTY PASSING THE FASTENER OVER THE ENDOTRACHEAL TUBE AND LOCKING THE FASTENER ONTO THE HOLDER. NO ADVERSE EFFECTS TO PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570333 PORTEX NEONATAL/PEDIATRIC TRACHEAL INTIBUATION KIT BTR - TUBE, TRACHEAL BTR SMITHS MEDICAL INTERNATIONAL LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK