BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPAN UTM-RT

    MDR report key: 4580961 · Received March 4, 2015

    Report

    Report Number
    3002444944-2015-00002
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    January 18, 2015
    Report Date
    January 27, 2015
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JSM
    PMA / PMN Number
    K042970
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF BATCH HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE CONTROLS MADE BEFORE THE RELEASE ON THE MARKET ON THE SWABS OF THE PRODUCT CODE 305C LOT NUMBER 20H614: LOT REPORTED IN THE INCIDENT MET MANUFACTURING SPECIFICATIONS. THE ORIGINAL LOT, MANUFACTURED IN 2014, WAS COMPRISED OF (B)(4) UNITS, THIS IS THE FIRST NOTIFICATION RECEIVED FOR THIS SPECIFIC LOT. THE DEVICE WAS NOT RETURNED TO COPAN FOR EVAL. MECHANICAL TEST ON THE RETAINED SAMPLE FROM THE CLAIMED LOT HAS BEEN PERFORMED: ALL THE TESTED SWABS GAVE CONFORMING RESULTS. WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. OUR INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTIONS OR DEFECTS IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS.

    Description of Event or Problem · 1

    THE EVENT OCCURED IN (B)(6). THE EVENT DESCRIPTION PROVIDED BY THE HOSP INDICATES THAT THE NURSE OPENED THE SWAB TO TAKE A NASOPHARYNGEAL SAMPLE FROM A (B)(6) FEMALE PT. THE SWAB WAS DIFFICULT TO REMOVE FROM THE PT AFTER SAMPLING AND REQUIRED TWISTING. ONLY THE BOTTOM PORTION OF THE SWAB WAS REMOVED, THE FLOCKED TIP REMAINED IN THE PATIENT'S NASAL CAVITY. THE SWAB WAS NOT FOUND BY THE ER PHYSICIAN OR NURSE AND THE PT WAS TRANSFERRED FROM THE ER TO ANOTHER PART OF THE HOSP THAT HAS AN EYE, THROAT, LUNG SPECIALIST AND KEPT FOR OBSERVATION FOR SEVERAL HOURS. THE OVERSEEING PHYSICAL CONCLUDED THAT THE PT HAD SWALLOWED THE SWAB SINCE IT WAS NOT FOUND IN THE THROAT/RESPIRATORY TRACT. NO ADDITIONAL COMMENTS FOLLOWING THE DISCHARGE OF THE PT WAS PROVIDED. NO EVIDENCE OF NEGATIVE OUTCOME ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151632 COPAN UTM-RT JSM COPAN ITALIA SPA 305C 20H614

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention