BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURG PAT XRAY 1X1 -200

    MDR report key: 10563590 · Received September 21, 2020

    Report

    Report Number
    3014334038-2020-00047
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    August 25, 2020
    Report Date
    August 25, 2020
    Manufacturer
    RAYNHAM
    Product Code
    HBA
    PMA / PMN Number
    K880402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFICATION (UDI) - (B)(4). THE SURGICAL PATTIE WAS RECEIVED FOR EVALUATION: DEVICE HISTORY RECORD - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - PER THE FAILURE ANALYST THIS PRODUCT IS PRODUCED IN AN ISO CLASS 8 CLEANROOM REQUIRING THE USE OF A HAIR NET AND LONG SLEEVE GOWNS. THIS HAIR APPEARS TO BE PRESENT FROM A HAIR NET FAILURE. THE OPERATOR WILL BE RETRAINED AND MADE AWARE OF THE ISSUE. PER THE COMPLAINT BACKGROUND, HAIR WRAPPED AROUND THE PATTIE CARD. THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. THE FAILURE ANALYST CONFIRMED THE ROOT CAUSE OF THIS ISSUE WAS OPERATOR ERROR (HAIR NET FAILURE).

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    UNIQUE DEVICE IDENTIFICATION (UDI)#: (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED, THEREFORE, MANUFACTURING RECORDS WERE REVIEWED, AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE HAIR WAS FOUND IN THE PACKAGING OF ITEM 801403 (SURG PAT XRAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024241 SURG PAT XRAY 1X1 -200 SURGICAL PATTIES HBA RAYNHAM J65K31

    Patients

    Seq Age Sex Outcome Treatment
    1