BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F) (ST

    MDR report key: 6341340 · Received February 17, 2017

    Report

    Report Number
    3006260740-2017-00110
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 18, 2017
    Report Date
    January 27, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    MSD
    UDI-DI
    00801741011986
    PMA / PMN Number
    K051748
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY 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 THAT PART OF THE PEEL AWAY SHEATH BROKE APART AND LEFT LITTLE SHARDS OF PLASTIC ON THE CATHETER DURING INSERTION IS INCONCLUSIVE DUE TO THE SAMPLE CONDITION. SIX PHOTOGRAPHS OF AN AIRGUARD INTRODUCER SHEATH AGAINST A BLUE TOWEL WERE PROVIDED FOR INVESTIGATION. THE PHOTOGRAPHS SHOW THAT THE SHEATH HAD BEEN SPLIT. IT APPEARS THAT THE VALVE SPLIT PROPERLY AND REMAINED ATTACHED BETWEEN THE TABS AND THE TOP CAP. BLOOD RESIDUE WAS OBSERVED THROUGHOUT THE SAMPLE. THE EDGES OF THE SPLIT SHEATH WERE SMOOTH AND CONSISTENT. WHAT APPEARED TO BE A WHITE PIECE OF MATERIAL WAS SHOWN ON THE BLUE TOWEL SEPARATE FROM THE SHEATH. FROM THE IMAGES PROVIDED, IT COULD NOT BE DETERMINED WHERE OR IF THE MATERIAL WAS ATTACHED TO THE INTRODUCER SHEATH. THE ENTIRE SURFACE OF THE SPLIT INTRODUCER SHEATH WAS NOT CAPTURED IN THE PROVIDED PHOTOGRAPHS. BASED ON THE EVIDENCE PROVIDED FOR INVESTIGATION, THE REPORTED EVENT COULD NOT BE VERIFIED. A LOT HISTORY REVIEW (LHR) OF REAY1190 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    FACILITY REPORTED TO THE SALES REP THAT PART OF THE PEEL AWAY SHEATH BROKE APART AND LEFT LITTLE SHARDS OF PLASTIC ON THE CATHETER DURING INSERTION. THE HEALTHCARE PROFESSIONAL HAD TO "PICK THEM OUT OF THE TRACT INTO THE VEIN". NO OTHER INFORMATION WAS PROVIDED OR PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124554 RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER WITH AIRGUARD STANDARD KIT (16F) (ST CATHETER, HEMODIALYSIS, IMPLANTED MSD BARD ACCESS SYSTEMS REAY1190 00801741011986

    Patients

    Seq Age Sex Outcome Treatment
    1