BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTW, 14.5FR, 23CM, ST, SPLIT TIP, STANDARD KIT

    MDR report key: 8491878 · Received April 8, 2019

    Report

    Report Number
    3006260740-2019-00810
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741013706
    PMA / PMN Number
    K090101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE LOT MET ALL RELEASE CRITERIA. DHR WAS REVIEWED AND NO DEVIATIONS/ISSUES WERE IDENTIFIED OR ASSOCIATED WITH THIS PROBLEM IN REGARDS TO PRODUCT MATERIALS OR DURING MANUFACTURING, PACKAGING OR QC INSPECTION PROCESS. ALL NECESSARY INSPECTIONS WERE PERFORMED THROUGHOUT ALL MANUFACTURING, PACKAGING AND INSPECTION ACTIVITIES AND FOR RAW MATERIAL UTILIZED IN THE MANUFACTURE OF THIS LOT IN REGARDS TO THE DESCRIBED PROBLEM. INVESTIGATION SUMMARY: ONE 14.5 FR D/L GLIDEPATH 23 CM STR HEMODIALYSIS CATHETER WITH SURECUFF KIT WAS RECEIVED WITH BOTH CLAMPS ENGAGED WAS RETURNED FOR EVALUATION. VISUAL AND MICROSCOPIC EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR DAMAGED/DEFECTIVE TUNNELER. THE EXACT ROOT CAUSE FOR THE DAMAGED TUNNELER COULD NOT BE DETERMINED. HOWEVER, IT IS LIKELY THAT SUPPLIER ISSUES MAY HAVE CONTRIBUTED TO REPORTED EVENT. CORRECTIVE ACTION HAS BEEN ISSUED TO TURNXON PRECISION CO. LTD TO ADDRESS THE DAMAGED TUNNELER ISSUE AND IDENTIFY APPROPRIATE ACTIONS. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. (EXPIRY DATE: 03/2020).

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC TIP OF THE TUNNELER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLASTIC TIP OF THE TUNNELER ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285630 OTW, 14.5FR, 23CM, ST, SPLIT TIP, STANDARD KIT LONG-TERM HEMODIALYSIS CATHETER MSD BARD ACCESS SYSTEMS 5903230 RECX3053 00801741013706

    Patients

    Seq Age Sex Outcome Treatment
    1