BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTFE FELT PLEDGETS

    MDR report key: 16465903 · Received March 2, 2023

    Report

    Report Number
    2020394-2023-00125
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 2, 2023
    Report Date
    April 4, 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 THIS MALFUNCTION IS CONSIDERED ONE EVENT IDENTIFIED BY THE DEALER; ONLY ONE MDR REPORT WILL BE SUBMITTED FOR THE REPORTED QUANTITY AFFECTED OF TWENTY FOR THIS EVENT. 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: 02/2027. DEVICE PENDING RETURN.

    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 TEN 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: ONE IMPRA EPTFE PATCHES WAS RECEIVED FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED CONTAMINATION ISSUES AS THE BLACK SPECS WERE NOTED IN THE PACKAGE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE 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: 02/2027). 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 DURING PREPARATION, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THERE WAS NO REPORTED PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION, A BLACK FOREIGN MATERIAL WAS ALLEGEDLY OBSERVED IN THE DEVICE PACKAGE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2001627 PTFE FELT PLEDGETS SURGICAL DXZ BARD PERIPHERAL VASCULAR, INC. 007970 HUGQ1386 00801741041341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown