BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETER

    MDR report key: 8592293 · Received May 8, 2019

    Report

    Report Number
    3006260740-2019-01295
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 11, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741012297
    PMA / PMN Number
    K051748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: MANUFACTURING RECORDS WERE REVIEWED (DHR, MRR¿S, SCRAP AND MFG. PROCESS CHANGES) AND THERE WERE NOT FOUND EVIDENCE THAT THE FAILURE MODE REPORTED IN THIS COMPLAINT IS CAUSED BY THE MFG. PROCESS. INVESTIGATION SUMMARY: BASED ON THE SAMPLE EVALUATION: ONE 14.5 FR D/L GLIDEPATH 19 CM STR HEMODIALYSIS CATHETER WITH SURECUFF KIT WAS RETURNED FOR EVALUATION. VISUAL AND MICROSCOPIC EVALUATIONS WERE PERFORMED. THE INVESTIGATION IS CONFIRMED FOR DAMAGED/DEFECTIVE TUNNELER, AS A BREAK WAS NOTED ON CONNECTER OF 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. VT-SCA-19-4398 HAS BEEN ISSUED TO TURNXON PRECISION CO. LTD TO ADDRESS THE DAMAGED TUNNELER 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. (EXPIRY DATE: 07/2020).

    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.

    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 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
    384507 GLIDEPATH® LONG-TERM HEMODIALYSIS CATHETER DIALYSIS CATHETER MSD BARD ACCESS SYSTEMS 5397190 RECZ1125 00801741012297

    Patients

    Seq Age Sex Outcome Treatment
    1