BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY PLN PKNG STRPS 2 X 5YD STRL

    MDR report key: 4915005 · Received July 15, 2015

    Report

    Report Number
    1018120-2015-00009
    Event Type
    Injury
    Date Received
    July 15, 2015
    Report Date
    July 1, 2015
    Manufacturer
    COVIDIEN
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR REVIEW BY THE CUSTOMER; HOWEVER, 3 PHOTOS OF A REPRESENTATIVE PRODUCT WERE PROVIDED. THE PHOTOS WERE EVALUATED FOR THE REPORTED CONDITION AND CLEARLY SHOWED PRODUCT CODE (B)(4), LOT # 14J159662X CORRECTLY SHOWING THE COTTON BALL AT THE END OF THE STRIP. ALTHOUGH THIS LOT NUMBER DOES NOT REPRESENT THE ACTUAL LOT NUMBER USED IN THE REPORTED CONDITION, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR LOT # 14J159662X AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE ISSUE DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THE INCIDENT OCCURRED DUE TO A USER ERROR. FOREIGN MATERIAL RETENTION INSIDE THE PATIENT IS A CRITICAL, WELL-KNOWN CLINICAL ADVERSE EVENT. IT IS THE HOSPITAL RESPONSIBILITY TO TRAIN CLINICIANS AND ESTABLISH AND MAINTAIN THE CLINICAL PRACTICE POLICY AND PROTOCOL TO PREVENT THIS TYPE OF INCIDENT. THERE HAVE BEEN NO CHANGES TO THE QUALITY CONTROL SAMPLING PLANS DEEMED NECESSARY. FUNCTIONAL TESTING AND VISUAL INSPECTIONS ARE BEING PERFORMED ACCORDING TO OUR CURRENT QUALITY STANDARDS AND INSPECTION PROCEDURES. THIS COMPLAINT WILL BE USED FOR TRENDING PURPOSES AND REVIEWED WITH PLANT MANAGEMENT.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 07/15/2015 AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. IT IS IMPORTANT TO NOTE THAT THIS COMPONENT IS NOT INTENDED TO BE USED IN THIS MANNER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 07/01/2015 THAT A CUSTOMER HAD AN ISSUE WITH A COTTON BALL. THE CUSTOMER STATES THAT THE COTTON BALL WRAPPED AT THE END OF THE GAUZE WAS RETAINED WHEN THE VAGINA WAS PACKED ON (B)(6) 2015. THE PATIENT RETURNED TO CLINICIAN ON (B)(6) 2015 FEELING POORLY. THE COTTON BALL WAS FOUND IN THE VAGINA. MEDICAL INTERVENTION REQUIRED INCLUDED REMOVAL OF THE COTTON BALL FROM THE VAGINA, ANTIBIOTICS WERE GIVEN, AND ADDITIONAL OUTPATIENT FOLLOW UP WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460419 CURITY PLN PKNG STRPS 2 X 5YD STRL PACKING STRIP FRO COVIDIEN 7634

    Patients

    Seq Age Sex Outcome Treatment
    1 Other