BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSEAL BONE FLAP KIT

    MDR report key: 18970525 · Received March 25, 2024

    Report

    Report Number
    2027062-2024-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 22, 2024
    Manufacturer
    BIOSEAL, INC.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPTNA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO OTHER COMPLAINTS OR REPORTS ARE ON FILE FOR OTHER BONE FLAP KITS USING THE SAME POUCHES. THE SUPPLIER WILL BE NOTIFIED OF THIS INCIDENT AND THE SITUAITON CLOSELY MONITORED. PIH HAS ADDED A STEP TO CONFIRM THAT THE CHEVRON IS SEALED PRIOR TO INSERTING THE BONE INTO THE SELF-SEALING POUCH. THE DRAWING WILL BE REVISED TO ADD AN INSPECTION TO CONFIRM THAT THE SELF-SEALING POUCH IS INTACT AT THE CHEVRON SIDE DURING ASSEMBLY OF THE KIT. THE ROOT CAUSE IS UNKNOWN AT THIS TIME BASED UPON THE INFORMATION RECEIVED AND REVIEWED. NO PATIENT INJURY OR COMPLICATION HAS BEEN REPORTED AT THE TIME OF THE FILING. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON 2/29/24 UNDER MEDWATCH MDR# MW5151353: DURING EMERGENT RIGHT CRANIECTOMY AT THE POINT WHEN THE CRANIAL BONE WAS BEING PLACED IN THE BIOSEAL BAG PRIOR TO PLACEMENT IN THE FREEZER AS THE CRANIAL BONE WAS BEING PLACED INTO THE SELF SEAL BAG, THE LOWER FACTORY SEALED PORTION OF THE BAG FAILED AND CRANIAL BONE FELL FROM THE BAG ONTO THE STERILE FIELD AND FELL TO THE FLOOR. CRANIAL BONE WAS SENT TO PATHOLOGY AND WILL BE RETAINED. PIH PURCHASES A CUSTOM BONE FLAP KIT FROM BIOSEAL. THE KIT CONTAINS TWO TYVEK POUCHES FOR SELF-SEALING AND RETAINING THE BONE FLAP AFTER REMOVAL. THE SELF-SEALING POUCHES ARE PURCHASED FROM A SUPPLIER UNDER RG# (B)(4), AND SUPPLIED IN THE KIT FOR PIH. ALL POUCHES REMAINING IN RAW GOODS INVENTORY WERE INSPECTED AND DID NOT INDICATE ANY DAMAGE TO THE MANUFACTURER'S SEAL AS RECEIVED FROM THE SUPPLIER. DURING THE ASSEMBLY PROCESS OF THE KIT; THE POUCHES ARE FOLDED AND PLACED INTO POCKETS AND NO DAMAGE WAS NOTED DURING THIS PROCESS OR IS ANTICIPATED WOULD BE CAUSED BY THIS PROCESS. REPORTED CALL ON 3/14/2024 WITH PIH BY (B)(6), SALES REPRESENTATIVE AND (B)(6), PRESIDENT/CEO. PIH SAID THEY ABSOLUTELY LOVE THE KIT AND IT IS WELL ORGANIZED AND THE INSTRUCTIONS ARE COMPLETE AND THOROUGH. THEY DID NOT PUT THE FLAP IN OUT OUTER POUCH, THEY USED IT FOLLOWING THE DIRECTIONS. THEY DID NOT DROP THE BONE FLAP FROM A DISTANCE. THEY INSERTED THE BONE FLAP AND WHEN THEY LIFTED THE POUCH THE BONE FELL OUT THROUGH THE CHEVRON END. AND THAT END OF THE POUCH WAS NOT SEALED AS IT SHOULD HAVE BEEN. NO OTHER COMPLAINTS OR REPORTS ARE ON FILE FOR OTHER BONE FLAP KITS USING THE SAME POUCHES. THE SUPPLIER WILL BE NOTIFIED OF THIS INCIDENT AND THE SITUAITON CLOSELY MONITORED. PIH HAS ADDED A STOPE TO VERIFY THAT THE SELF-SEALING BAG IS INTACT BEFORE ADDED THE BONE. THE DRAWING WILL BE REVISED TO ADD AN INSPECTION TO CONFIRM THAT THE SELF-SEALING POUCH IS INTACT AT THE CHEVRON SIDE DURING ASSEMBLY OF THE KIT. THE ROOT CAUSE IS UNKNOWN AT THIS TIME BASED UPON THE INFORMATION RECEIVED. PIH DID NOT WANT A CREDIT OR TO RETURN EXISTING INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461047 BIOSEAL BONE FLAP KIT BONE FLAP KIT KDD BIOSEAL, INC. PIH001/05 400660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention