BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTFE FELT PLEDGETS

    MDR report key: 16671801 · Received April 4, 2023

    Report

    Report Number
    2020394-2023-00218
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 7, 2023
    Report Date
    August 24, 2023
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    UDI-DI
    00801741041341
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. EXPIRY DATE: 03/2027. 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. DEVICE PENDING RETURN.

    Additional Manufacturer Narrative · 0

    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: SIX IMPRA EPTFE PATCHES WERE RETURNED FOR EVALUATION. ON VISUAL EVALUATION, BLACK SPECS WERE NOTED WITHIN THE INSIDE OF OUTER PACKAGING OF SAMPLE TWO, AND BLACK SPECS WERE NOTED WITHIN THE INSIDE OF INNER PACKAGING OF SAMPLES THREE, FOUR, FIVE AND SIX. NO VISUAL ANOMALIES WERE NOTED FOR SAMPLE ONE. THEREFORE, THE INVESTIGATION FOR THE REPORTED FOREIGN MATERIAL IS CONFIRMED FOR THE RETURNED FIVE DEVICES. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED FOREIGN MATERIAL 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. D4 (EXPIRY DATE: 03/2027). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE CONTAMINATION OF FOREIGN MATERIAL WAS ALLEGEDLY FOUND. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900787 PTFE FELT PLEDGETS SURGICAL DXZ BARD PERIPHERAL VASCULAR, INC. 007970 HUGR0715 00801741041341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown