BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PATXRAY 1/2X1/2-200

    MDR report key: 16684696 · Received April 5, 2023

    Report

    Report Number
    3014334038-2023-00046
    Event Type
    Malfunction
    Date Received
    April 5, 2023
    Report Date
    July 12, 2023
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    UDI-DI
    10381780514961
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 PATTIE (ID: 801400) 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: COMPLAINT SAMPLE REVIEWED AND CONFIRMED, FOREIGN MATERIAL PRESENT IN SEALED PACKAGE. OPERATORS ARE TRAINED TO INSPECT PACKAGES TO ENSURE THEY ARE FREE OF DEBRIS. PER PROCEDURE, "THERE SHALL BE NO LOOSE PARTICLES OR FOREIGN MATTER IN THE FLEXIBLE BLISTER LARGER THAN .80 SQ MM IN ANY DIMENSION AND THERE SHALL BE NO MORE THAN FIVE PARTICLES .25 SQ MM OR LARGER, MEASURED WITH THE TRANSPARENT CHART FOR ESTIMATION OF DEFECT SIZE. ROOT CAUSE: THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. CURRENTLY THE COMPLAINT ISSUE DOES NOT REPRESENT AN ADVERSE TREND, HOWEVER THE ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED THROUGH THE COMPLAINT EVALUATION PROCESS. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. THE ROOT CAUSE IS OPERATOR ERROR.

    Description of Event or Problem · 0

    A FACILITY REPORTED A SMALL ORANGE FOREIGN OBJECT WITHIN THE PACKAGING OF A SURGICAL PATTIE (ID 801400). THE ISSUE WAS DETECTED DURING PRE-SURGERY AND NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285236 SURG PATXRAY 1/2X1/2-200 SURGICAL PATTIES HBA RAYNHAM 801400 6396472 10381780514961

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown