BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® SELDINGER CHEST DRAINAGE KIT

    MDR report key: 7828393 · Received August 29, 2018

    Report

    Report Number
    3012307300-2018-03568
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    August 2, 2018
    Report Date
    July 26, 2019
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    PYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION RESULTS: ONE USED PLEURAL CATHETER WAS RETURNED FOR INVESTIGATION. THE INVESTIGATORS CONFIRMED THE CUSTOMER REPORTED PROBLEM REGARDING THE 1 CM LONG LONGITUDINAL CRACK AT THE SCREW ATTACHMENT OF THE DRAIN. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. THE INVESTIGATORS CONCLUDED THAT THE INCIDENT WAS NOT DUE TO A PRODUCT FAILURE. AN EXACT ROOT CAUSE FOR THE REPORTED FAILURE WAS NOT DETERMINED HOWEVER.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT AN AIR FISTULA WAS DETECTED LEADING TO LEAKING OF THE SMITHS MEDICAL PORTEX® SELDINGER CHEST DRAINAGE SYSTEM. THE DRAIN WAS REMOVED AS THE LEAK WAS UNABLE TO BE FOUND. UPON VISUAL EXAMINATION OF THE DRAIN, A 1 CM LONG LONGITUDINAL CRACK WAS NOTED AT THE SCREW ATTACHMENT OF THE DRAIN. IT WAS REPORTED THAT THE DRAINAGE SYSTEM WAS NOT REMOVING CEREBRAL SPINAL FLUID (CSF) AS IT WAS SUPPOSED TO BUT AFTER THE SYSTEM CHANGE OUT, 100MLS OF CSF DRAINED. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668715 PORTEX® SELDINGER CHEST DRAINAGE KIT THORACIC CATHETER INSERTION TRAY PYI SMITHS MEDICAL ASD; INC. 3566212

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R