BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AV SHEATH TUNNELER

    MDR report key: 12922863 · Received December 3, 2021

    Report

    Report Number
    2020394-2021-02032
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    November 8, 2021
    Report Date
    April 4, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KCT
    UDI-DI
    00801741090530
    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

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (EXPIRY DATE: 09/2024). DEVICE NOT RETURNED.

    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: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INSTRUCTION FOR RE-STERILIZATION PROCESS OUTLINED WITHIN THE INSTRUCTIONS FOR USE DOES NOT MATCH EXACTLY THE RKI GUIDELINE RECOMMENDATIONS, THE INSTRUCTIONS PROVIDED WITHIN THE INSTRUCTIONS FOR USE HAS BEEN VALIDATED AS BEING CAPABLE OF PREPARING THE TUNNELER FOR SURGICAL USE. PER THE INSTRUCTIONS FOR USE, ¿IT REMAINS THE RESPONSIBILITY OF THE PROCESSING FACILITY TO ENSURE THAT PROCESSING OF THE DEVICE BEFORE USE/ REUSE USING APPROPRIATE EQUIPMENT, MATERIALS, AND PERSONNEL ACHIEVES THE DESIRED RESULT. THIS REQUIRES VERIFICATION AND/OR VALIDATION AND ROUTINE MONITORING OF THE PROCESS. ALSO RKI IS A SET OF GUIDELINES. THE VERBIAGE WITHIN THE RKI GUIDELINES STATES ¿RECOMMENDED¿. THEREFORE, THE INVESTIGATION IS UNCONFIRMED FOR INADEQUATE INSTRUCTIONS FOR USE ISSUE AS THE PROVIDED INFORMATION WITHIN THE INSTRUCTION FOR USE IS FOUND TO BE ADEQUATE. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED INADEQUATE OPERATING INSTRUCTIONS COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G., PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 09/2024). H11:SECTION A THROUGH F - 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE REPROCESSING INSTRUCTION OUTLINED WITH THE DEVICE WAS NOT IN COMPLIANCE WITH THE GERMAN LAW. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE REPROCESSING INSTRUCTION OUTLINED WITH THE DEVICE WAS NOT IN COMPLIANCE WITH THE GERMAN LAW. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825743 AV SHEATH TUNNELER SURGICAL TUNNELER KCT BARD PERIPHERAL VASCULAR, INC. AVST2000 VTDW0149 00801741090530

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown