BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1X1 -200

    MDR report key: 17780648 · Received September 20, 2023

    Report

    Report Number
    3014334038-2023-00159
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 25, 2023
    Report Date
    October 4, 2024
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    UDI-DI
    10381780514992
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SURGICAL PATTIES (ID 801403) WERE 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. 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.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE SURGICAL PATTIES (ID (B)(6)) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - THE COMPLAINT CAN BE CONFIRMED. A LARGE HAIR WAS FOUND CONTAINED WITHIN THE BLISTER. ROOT CAUSE ANALYSIS - THE ROOT CAUSE IS UNDETERMINED AND WAS ABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. PER THE EVALUATOR, ROOT CAUSE IS IMPROPER USE OF A HAIR NET PER PROCEDURE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    A FACILITY REPORTED A PACKAGE OF SURGICAL PATTIES (ID 801403) WITH A THIN STRAND OF BLACK HAIR IN IT. IT CAN BE SEEN THROUGH THE UNOPENED PACKAGE AND DISCOVERED IN STERILE CORE. THE PACKAGE WAS LEFT UNOPENED. NO PATIENT CONTACT, IT WAS DETECTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589283 SURG PAT XRAY 1X1 -200 SURGICAL PATTIES HBA RAYNHAM 6775024 10381780514992

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown