BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCOR DRIVER

    MDR report key: 12758188 · Received November 7, 2021

    Report

    Report Number
    2020394-2021-01942
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 10, 2021
    Report Date
    March 2, 2022
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741086076
    PMA / PMN Number
    K040842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD REVIEW AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE DEVICE WAS NOT RETURNED. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS OR VIDEO WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURE AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE SN DISCREPANCY 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: 06/2045), G3. H11: D4 (MEDICAL DEVICE SERIAL #), E1, G2, H6 (RESULT, CONCLUSION). 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.

    Additional Manufacturer Narrative · 0

    AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 06/2045). DEVICE PENDING RETURN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SERIAL NUMBER ON THE INNER LABEL DID NOT MATCH WITH THE OUTER BOX SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SERIAL NUMBER ON THE INNER LABEL DID NOT MATCH WITH THE OUTER BOX SERIAL NUMBER. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659961 ENCOR DRIVER BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. DRENCOR 00801741086076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown