BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PATXRAY 1/2X1/2-200

    MDR report key: 16019237 · Received December 20, 2022

    Report

    Report Number
    3014334038-2022-00279
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    August 29, 2022
    Report Date
    December 20, 2022
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    UDI-DI
    10381780514961
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SURGICAL PATTIES (ID 801400)  WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. HOWEVER, A PROBABLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS IMPROPER X-RAY WELD. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WAS IMPLEMENTED PREVENTATIVE ACTIONS TO MINIMIZE THE ISSUES FOR THE PATTIES/STRIPS PRODUCT FAMILY RELATED TO DISCOLORATION, INCORRECT COUNT, STRING ISSUES, AND X-RAY DETECTABILITY.

    Description of Event or Problem · 0

    A FACILITY REPORTED THE SURGICAL PATTIES (ID 801400) DID NOT SHOW UP ON X-RAY. THEY EVEN TESTED OUTSIDE OF BODY ON THE FIELD. NO PATIENT INJURY REPORTED AND THE EVENT DID NOT LED TO SURGICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141484 SURG PATXRAY 1/2X1/2-200 SURGICAL PATTIES HBA RAYNHAM 801400 5372127 10381780514961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown