BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTFE FELT PLEDGETS

    MDR report key: 18825092 · Received March 4, 2024

    Report

    Report Number
    2020394-2024-00301
    Event Type
    Injury
    Date Received
    March 4, 2024
    Date of Event
    January 25, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    UDI-DI
    00801741041358
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. HOWEVER, A PHOTO WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 05/2027). 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 : 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: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. NO PHOTOS WERE PROVIDED FOR REVIEW. THEREFORE, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FAILURES AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED LEAK AND MIGRATION ISSUES COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. (EXPIRATION DATE: 05/2027), (DEVICE, METHOD) (RESULT, CONCLUSION) 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, DURING HAEMOSTASIS, AT THE SECOND CLAMPING, THE NEW AORTIC SUTURE WAS ALLEGEDLY LOOSENED WITH A MASSIVE LEAKAGE WHICH REQUIRED A THIRD ONE HUNDRED AND SEVENTY SIX MINUTE CLAMPING. IT WAS FURTHER REPORTED THAT THE TEFLON PATCH ALLEGEDLY WENT INTO THE PATIENT'S BLOODSTREAM. REPORTEDLY, THE PATIENT WAS NEEDED TO BE REOPENED AND WAS PLACED UNDER CARDIOVASCULAR EXAMINATIONA ALONG WITH RAPID RECOVERY AND CLOSE NEUROLOGICAL MONITORING WAS DONE DUE TO THE MISSING PIECE OF TEFLON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL GRAFT PLACEMENT PROCEDURE, DURING HAEMOSTASIS, AT THE SECOND CLAMPING, THE NEW AORTIC SUTURE WAS ALLEGEDLY LOOSENED WITH A MASSIVE LEAKAGE WHICH REQUIRED A THIRD ONE HUNDRED- AND SEVENTY-SIX-MINUTE CLAMPING. IT WAS FURTHER REPORTED THAT THE TEFLON PATCH ALLEGEDLY WENT INTO THE PATIENT'S BLOODSTREAM. REPORTEDLY, THE PATIENT WAS NEEDED TO BE REOPENED AND WAS PLACED UNDER CARDIOVASCULAR EXAMINATION ALONG WITH RAPID RECOVERY AND CLOSE NEUROLOGICAL MONITORING WAS DONE DUE TO THE MISSING PIECE OF TEFLON. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194760 PTFE FELT PLEDGETS SURGICAL DXZ BARD PERIPHERAL VASCULAR, INC. HUGT1667 00801741041358

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention