BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRO, 4F SL, 60CM, W/3CG BEDSIDE

    MDR report key: 6817812 · Received August 24, 2017

    Report

    Report Number
    3006260740-2017-01434
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Report Date
    September 26, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741107894
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REBS2432 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF AN OCCLUDED CATHETER WAS CONFIRMED AND THE CAUSE WAS USE-RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4FR S/L GROSHONG CATHETER. THE SAMPLE WAS RECEIVED ASSEMBLED WITH A TWO-PIECE CONNECTOR. THE SAMPLE TERMINATED WITHIN THE REGION OF THE CLEAR STRAIN-RELIEF SLEEVE. AN ATTEMPT TO INFUSE WATER THROUGH THE SAMPLE USING A 12ML SYRINGE REVEALED THE SAMPLE TO BE FULLY OCCLUDED. FOLLOWING DISASSEMBLY OF THE CONNECTOR, INSPECTION OF THE BORE REVEALED THAT THE CATHETER WAS NOT FULLY INSERTED THROUGH THE DISTAL SEGMENT. FOLLOWING LONGITUDINAL BISECTION OF THE DISTAL SEGMENT, INSPECTION OF THE CATHETER REVEALED THAT IT WAS KINKED BETWEEN THE COMPRESSION SLEEVE AND THE DISTAL END OF THE CONNECTOR. THE CATHETER WAS NOT FULLY INSERTED THROUGH THE COMPRESSION SLEEVE. MICROSCOPIC INSPECTION OF THE SAMPLE CONFIRMED THAT THE CATHETER WAS NOT FULLY INSERTED THROUGH THE COMPRESSION SLEEVE AND HAD BEEN KINKED BETWEEN THE SLEEVE AND THE DISTAL END OF THE CONNECTOR. THE OBSERVED INABILITY TO FLUSH THROUGH THE SAMPLE WAS CAUSED BY THE KINKED CATHETER WITHIN THE CONNECTOR. THE KINK APPEARED TO BE CAUSED BY FAILING TO FULLY INSERT THE CATHETER THROUGH THE COMPRESSION SLEEVE PRIOR TO ASSEMBLY. THE PRODUCT IFU PROVIDES INSTRUCTIONS FOR PROPER ASSEMBLY OF THE CATHETER/CONNECTOR SYSTEM. A LOT HISTORY REVIEW (LHR) OF REBS2432 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    LINE WOULD NOT FLUSH. NO OTHER INFORMATION PROVIDED.

    Description of Event or Problem · 1

    LINE WOULD NOT FLUSH. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596967 GRO, 4F SL, 60CM, W/3CG BEDSIDE PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS REBS2432 00801741107894

    Patients

    Seq Age Sex Outcome Treatment
    1