BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUM INSTRUMENT

    MDR report key: 16369798 · Received February 14, 2023

    Report

    Report Number
    2020394-2023-00064
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 21, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    UDI-DI
    00801741083945
    PMA / PMN Number
    K934371
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE SERIAL 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. (EXPIRY DATE: 12/2050).

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A DEVICE HISTORY RECORD AND MANUFACTURING REVIEW WAS NOT REQUIRED AS THE EVENT WAS DETERMINED TO BE EXPECTED AND THE INVESTIGATION DID NOT IDENTIFY ANY MANUFACTURING AND/OR SERVICE-RELATED ISSUES. INVESTIGATION SUMMARY: THE MAGNUM DRIVER WAS RETURNED FOR EVALUATION. THE MAGNUM DRIVER WAS VISUALLY INSPECTED UPON RECEIPT AND WAS FOUND TO BE IN GOOD CONDITION. ALSO DISCOLORED PLASTICS IDENTIFIED DURING EVALUATION. THE DEVICE WAS FUNCTIONALLY TESTED AND FAILED THE TESTS AS BENT SEQUENCER WELDMENT ASSEMBLY TAB. NO OTHER ANOMALIES WERE IDENTIFIED. THEREFORE, THE INVESTIGATION IS DETERMINED TO BE CONFIRMED FOR THE REPORTED DEVICE DOESN'T PRIME CORRECTLY. THE ROOT CAUSE FOR THE REPORTED DEVICE DOESN'T PRIME CORRECTLY WAS DETERMINED TO BE BENT SEQUENCER WELDMENT ASSEMBLY TAB. 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: 12/2050), G3. H11: H6 (METHOD, RESULT, CONCLUSION). H11: SECTION A THROUGH F: THE INFORMATION PROVIDE 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE DOESN'T PRIME CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE DOESN'T PRIME CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211436 MAGNUM INSTRUMENT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. MG1522 00801741083945

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown