BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON CORR-A-FLEX TUBING, 100 FT ROLL

    MDR report key: 3929702 · Received February 11, 2014

    Report

    Report Number
    3004365956-2014-00058
    Event Type
    Death
    Date Received
    February 11, 2014
    Date of Event
    December 1, 2013
    Report Date
    January 15, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO DHR (DEVICE HISTORY RECORD) RELATED TO THE CUSTOMER COMPLAINT WAS REVIEWED BECAUSE THE CUSTOMER DID NOT PROVIDE LOT NUMBER OF THE PRODUCT 1680. HOWEVER THE DHR # (B)(4) RELATED TO THE LAST RAN OF THE CODE 1680 WERE REVIEWED AN THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. A CORRECTIVE ACTION CANNOT BE APPLIED. IN ORDER TO PERFORM PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFO PROVIDED, IN ORDER TO PERFORM A PROPER INVESTIGATION IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED ON THE INCIDENT. HOWEVER, CURRENT PRODUCTION WAS VERIFIED TO IDENTIFY ANY ISSUE THAT CAN LEAD TO THE REPORTED DEFECT BY MEASURING THE INTERNAL DIAMETER AND LIP WIDTH OF THE COMPONENT BATCH# (B)(4) AND THOSE DIMENSIONS WERE WITHIN SPECIFICATIONS ACCORDING TO DRAWING # DWG 1680 REVISION 02. ALSO ALL PERSONNEL FROM THE PRODUCTION LINE WERE NOTIFIED TO MAKE THEM AWARE OF THIS ISSUE. IF THE PRODUCT BECOMES AVAILABLE THIS INVESTIGATION WILL BE UPDATED WITH THE EVAL RESULTS.

    Description of Event or Problem · 1

    THE PT IS REPORTED AS: ON (B)(6) 2014, RUSCH (B)(4) WAS INFORMED BY THE POLICE (CONTACT MRS. (B)(4)) THAT A HOME-CARE PT HAD DIED BECAUSE A CORR-A-FLEX TUBE (CATALOG# 1680) DISCONNECTED. TO DATE, NO FURTHER INFO WAS RECEIVED FROM THE DISTRIBUTOR OR THE POLICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89149 HUDSON CORR-A-FLEX TUBING, 100 FT ROLL CORRUGATED TUBING BZO TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death