BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR SAFETY TOWEL

    MDR report key: 5651493 · Received May 12, 2016

    Report

    Report Number
    3010452421-2016-00009
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 8, 2016
    Report Date
    May 12, 2016
    Manufacturer
    US MEDCO, INC.
    Product Code
    FRL
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE ROOT CAUSE IS UNDETERMINED. THE RAW MATERIAL USED WITHIN THE FINISHED GOOD IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN ITS SCAR RESPONSE, (B)(4) STATED RETAINED SAMPLES WERE SENT TO A THIRD-PARTY LABORATORY FOR TESTING. BASED ON THE TEST RESULTS, THE MANUFACTURER WAS UNABLE TO CONFIRM THE COMPLAINT. CORRECTIVE ACTION: ACCORDING TO THE SCAR RESPONSE, (B)(4) HAS REINFORCED THE INSPECTION IN THE DELINT AND FOLDING PROCESSES TO DETECT ANY PRESENCE OF LINT ACCUMULATION ON THE FABRIC AND FOLDING TABLETOPS. (B)(4) ALSO PERFORMED TRAINING. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING AN OR TOWEL (FINISHED (B)(4), LOT NUMBER 40950078) LEFT LINT ON A PATIENT DURING A PROCEDURE, WHICH CAUSED A DELAY OF ABOUT 15-20 MINUTES. THE DEROYAL COMPLAINT SPECIALIST REVIEWED THE WORK ORDER FOR DISCREPANCIES, BUT NONE WERE IDENTIFIED. THE REPORTED FINISHED GOOD CONTAINED RAW MATERIAL (B)(4), LOT NUMBER A32327, WHICH IS SUPPLIED BY (B)(4). THEREFORE, A SCAR WAS ISSUED TO THE SUPPLIER AND RETURNED MAY 5,2016. IN ITS SCAR RESPONSE, (B)(4) REPORTED IT SENT RETAINED SAMPLES TO A THIRD-PARTY LABORATORY TO PERFORM A TEST IN ACCORDANCE WITH (B)(4), WHICH IS A (B)(4) TEST METHOD USED TO DETECT PILLING OR LINT. THIS TEST METHOD IS BASED ON THE STANDARD (B)(4) (STANDARD TEST METHOD FOR PILLING RESISTANCE AND OTHER RELATED SURFACE CHANGES OF TEXTILE FABRICS: RANDOM TUMBLE PILLING TESTER). (B)(4) REQUESTED TWO TESTS BE PERFORMED: ONE WITHOUT WASHING AND THE OTHER WITH WASHING. THE TESTS ULTIMATELY CONCLUDED THE PILLING ON THE TOWELS WAS BETWEEN A LIGHT PILLING FORMATION AND NO PILLING FORMATION. BASED ON THESE RESULTS, THERE IS NO PROBABILITY TO HAVE LOOSENING OF LINT ON THE TOWELS. PREVENTIVE ACTION: A PREVENTIVE ACTION IS NOT BEING TAKEN. THE INVESTIGATION IS COMPLETE. THIS REPORT WILL BE UPDATED IF NEW AND CRITICAL INFORMATION IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT WAS PREPPED WITH SOLUTION, AND WHEN WIPED WITH THE OR TOWEL, A LOT OF LINT FROM THE TOWEL WAS LEFT BEHIND ON THE PATIENT. THE PROCEDURE WAS DELAYED ABOUT 15-20 MINUTES TO CLEAN UP THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307049 OR SAFETY TOWEL FIBER, MEDICAL, ABSORBENT FRL US MEDCO, INC. 409500578

    Patients

    Seq Age Sex Outcome Treatment
    1