BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEPATH, 14.5F, 23CM, ST, STD KIT

    MDR report key: 8496097 · Received April 9, 2019

    Report

    Report Number
    3006260740-2019-00819
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Date of Event
    March 13, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741012181
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: THE LOT MET ALL RELEASE CRITERIA. A 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 WAS RETURNED FOR EVALUATION. GROSS VISUAL AND MICROSCOPIC VISUAL EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR DAMAGED/DEFECTIVE TUNNELER, AS THE SAMPLE EVALUATION CONFIRMED A BROKEN TUNNELER TIP AND THIS IS A KNOWN ISSUE FOR GLIDEPATH TUNNELERS. THE END FRAGMENT OF THE CATHETER LOADING TIP ON THE TUNNELER WAS BROKEN IN TWO PIECES AND THE BREAK SURFACE PROFILES MATCHED ONE ANOTHER. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. HOWEVER, IT IS LIKELY THAT SUPPLIER RELATED ISSUES CONTRIBUTED TO THE REPORTED EVENT. CORRECTIVE ACTION HAS BEEN ISSUED TO TURNXON PRECISION CO. LTD TO ADDRESS THE ISSUE AND IDENTIFY APPROPRIATE ACTIONS. LABELING REVIEW: AS THIS COMPLAINT HAS BEEN FOUND TO BE MANUFACTURING/SUPPLIER RELATED, A REVIEW OF PRODUCT LABELING DOCUMENTS (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) IS NOT APPLICABLE. PRODUCT LABELING WOULD NOT HAVE PREVENTED THIS ISSUE. THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF THE INSERTION PROCEDURE WHILE ATTEMPTING TO ATTACH THE TUNNELER COMPONENT TO THE DIALYSIS CATHETER, THE PLASTIC PIECE ON THE TUNNELER BROKE OFF. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION OF THE INSERTION PROCEDURE WHILE ATTEMPTING TO ATTACH THE TUNNELER COMPONENT TO THE DIALYSIS CATHETER, THE PLASTIC PIECE ON THE TUNNELER BROKE OFF. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289044 GLIDEPATH, 14.5F, 23CM, ST, STD KIT DIALYSIS CATHETER MSD BARD ACCESS SYSTEMS 5393230 RECX0998 00801741012181

    Patients

    Seq Age Sex Outcome Treatment
    1