BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TS ADMIN SET-BBRAUN (990264.SPE)-1 BOX

    MDR report key: 13595277 · Received February 24, 2022

    Report

    Report Number
    2134265-2022-02049
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    January 28, 2022
    Report Date
    June 21, 2022
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVAL BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. A VISUAL INSPECTION WAS PERFORMED TO ATTEMPT TO CONFIRM THE REPORT OF FOREIGN MATERIAL IN THE DEVICE. THE MATERIAL WAS SEEN IN THE DEVICE BUT WAS UNABLE TO BE IDENTIFIED. THE DEVICE IS BEING SENT TO THE SUPPLIER FOR FURTHER ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE DEVICE. A THERASPHERE ADMIN SET WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PRIMING PHASE UPON REMOVING THE SYRINGE TO DISCARD THE AIR, A FOREIGN BODY WAS OBSERVED IN THE TUBING. THE TUBING WAS SET ASIDE AND NOT USED. THE TUBING WAS NEVER ATTACHED TO THE DOSE. ANOTHER ADMIN SET WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE DEVICE. A THERASPHERE ADMIN SET WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PRIMING PHASE UPON REMOVING THE SYRINGE TO DISCARD THE AIR, A FOREIGN BODY WAS OBSERVED IN THE TUBING. THE TUBING WAS SET ASIDE AND NOT USED. THE TUBING WAS NEVER ATTACHED TO THE DOSE. ANOTHER ADMIN SET WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATERIAL IN THE DEVICE. A THERASPHERE ADMIN SET WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PRIMING PHASE UPON REMOVING THE SYRINGE TO DISCARD THE AIR, A FOREIGN BODY WAS OBSERVED IN THE TUBING. THE TUBING WAS SET ASIDE AND NOT USED. THE TUBING WAS NEVER ATTACHED TO THE DOSE/LED PIG. ANOTHER ADMIN SET WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1230259 TS ADMIN SET-BBRAUN (990264.SPE)-1 BOX MICROSPHERES RADIONUCLIDE NAW BIOCOMPATIBLES UK LTD 2361-07 0061759462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown