BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLECTION SET TUBING PVC (10/PK)

    MDR report key: 20077401 · Received August 27, 2024

    Report

    Report Number
    3011050570-2024-00346
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 17, 2024
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HHI
    UDI-DI
    00821925030954
    PMA / PMN Number
    K030935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE RESULTS OF THE DEVICE EVALUATION, THE LEGAL MANUFACTURER'S FINAL INVESTIGATION, AND INFORMATION RECEIVED FROM THE CUSTOMER. ADDITIONAL INFORMATION ADDED TO THE FOLLOWING FIELDS: B5, D9, E2, E3, G2 (ADDED SELECTION), H3, H4, H6 THE DEVICE WAS RETURNED TO OLYMPUS UNOPENED AND IN ITS ORIGINAL PACKAGING. UPON INSPECTION, A SINGULAR HALF INCH PIECE OF HAIR WAS FOUND INSIDE. THE CUSTOMER'S REPORTED ISSUE WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN LESS THAN A YEAR SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE COLLECTION SET TUBING PACKAGE HAD A HAIR IN IT. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED. THE DEBRIS IN THE PACKAGE WAS FOUND DURING PREPARATION FOR USE AND IT WAS DISCOVERED PRIOR TO OPENING THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25271 COLLECTION SET TUBING PVC (10/PK) COLLECTION SET TUBING PVC (10/PK) HHI GYRUS ACMI, INC. 23116 S240100636 00821925030954

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown