BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTFE FELT PLEDGETS

    MDR report key: 16858340 · Received May 3, 2023

    Report

    Report Number
    2020394-2023-00306
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 5, 2023
    Report Date
    July 10, 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

    H10: AS THIS MALFUNCTION IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF THIRTY FOR THIS EVENT. 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: 06/2027).

    Additional Manufacturer Narrative · 0

    H10: AS THIS MALFUNCTION IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF FORTY FOR THIS EVENT. 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: FOUR IMPRA EPTFE PATCHES WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, SAMPLE ONE AND FOUR WAS NOTED TO HAVE BLACK SPECS AND YELLOW DISCOLORATION FOREIGN MATERIAL WERE NOTED WITHIN INNER PACKAGING. SAMPLE TWO AND THREE WAS NOTED TO HAVE BLACK SPECS WITHIN INNER PACKAGING. NO FUNCTIONAL PERFORMED DUE TO THE NATURE OF THE COMPLAINT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE FOR THE REPORTED CONTAMINATION ISSUE. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED CONTAMINATION ISSUE 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 (EXPIRATION DATE: 06/2027), G3 H11: 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A MICRO FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGE, A MICRO FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160114 PTFE FELT PLEDGETS SURGICAL DXZ BARD PERIPHERAL VASCULAR, INC. 007970 HUGU1955 00801741041341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown