BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIPHERAL VASCULAR SHEATH TUNNELER

    MDR report key: 19825523 · Received July 25, 2024

    Report

    Report Number
    2020394-2024-01106
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 27, 2024
    Report Date
    November 21, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KCT
    UDI-DI
    00801741090257
    PMA / PMN Number
    K042062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 02/2027) H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE COMPLETE PV SHEATH TUNNELER SET WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, ALL COMPONENTS OF THE KIT APPEARED TO BE PRESENT. THE SAMPLES APPEARED TO BE CLEAN. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR THE REPORTED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL AND MATERIAL EROSION AS ALL KIT COMPONENTS WERE PRESENT AND ALL APPEARED TO BE CLEAN. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED DEVICE CONTAMINATION WITH CHEMICAL OR OTHER MATERIAL AND MATERIAL EROSION COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H11: D2B (MZY; KCT), D4 (UNIQUE IDENTIFIER (UDI) #), H6 (METHOD, RESULT, CONCLUSION). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 A SURGICAL GRAFT PLACEMENT PROCEDURE, AFTER STERILIZATION, SOME MATERIALS WERE ALLEGEDLY FOUND TO BE DISSOLVED FROM THE SET. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, AFTER STERILIZATION, SOME MATERIALS WERE ALLEGEDLY FOUND TO BE DISSOLVED FROM THE SET. IT WAS FURTHER REPORTED THAT THEY SAW BLACK PARTICLES ON THE GRAFT PROTHESIS AFTER THEY PUT IT INSIDE THE TUNNELER. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365289 PERIPHERAL VASCULAR SHEATH TUNNELER SURGICAL OTHER KCT BARD PERIPHERAL VASCULAR, INC. VTGN0274 00801741090257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown