BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESWAB

    MDR report key: 6108730 · Received November 17, 2016

    Report

    Report Number
    3002444944-2016-00003
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 17, 2016
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JTW
    PMA / PMN Number
    K061301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION HAS BEEN PERFORMED AND IS PRESENTED IN THIS SECTION. AN ANALYSIS OF THE RECEIVED INFORMATION HAS BEEN PERFORMED: PATIENT (MALE, AGED (B)(6)) WAS RELUCTANT TO HAVE SWAB PERFORMED AND NOT SEDATED DURING THE SAMPLING. THE BOY BIT THE SWAB AT THE RED LINE CAUSING ITS BREAKAGE AT THE BREAKING POINT, AND THIS HAS BEEN IDENTIFIED AS THE CAUSE OF THE EVENT. NO INJURY ON THE PATIENT WAS REPORTED BECAUSE THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED. MOREOVER IT WAS REPORTED THAT THE COLLECTION WAS PERFORMED AT THE SAME TIME USING TWO DIFFERENT SWABS IN THE SAME COLLECTION SITE. ANALYSIS OF DEVICE HISTORY RECORDS: COPAN CHECKED THE INTERNAL RECORDS RELATED TO THE MANUFACTURING AND CONTROLS BEFORE THE RELEASE ON THE MARKET OF THE REPORTED PRODUCT 480C, LOT NUMBER 4QN700 (287400 PIECES). NO ANOMALIES HAVE BEEN FOUND. THIS IS THE (B)(4) EVENT RECEIVED ON THIS PRODUCT CODE AND LOT NUMBER. THE INVOLVED DEVICE WAS NOT RETURNED TO COPAN FOR EVALUATION SINCE IT WAS WASTED, THEREFORE NO ANALYSIS HAS BEEN PERFORMED ON THE RETRIEVED PIECE OF PRODUCT. AN ANALYSIS OF THE INCIDENCE OF THE PROBLEM HAS BEEN PERFORMED: THIS IS THE FIRST COMPLAINT RECEIVED OF THIS KIND. CONSIDERING THAT THE INTERNAL INVESTIGATION COULD NOT CONFIRM ANY MALFUNCTIONS/DEFECTS IN THE DEVICE LOT ASSOCIATED WITH THIS INCIDENT, THAT TO OUR KNOWLEDGE NO EVENT HAS LED TO SERIOUS MEDICAL CONSEQUENCES SO FAR IN SIMILAR CIRCUMSTANCES (BREAKAGE OF THE SWAB DURING COLLECTION) AND THAT THE INCIDENCE RATE IS VERY RARE, NO CORRECTIVE ACTIONS IS PLANNED AT THIS TIME. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    ON OCTOBER 21ST, 2016 WE RECEIVED AN EMAIL INFORMING THAT: "END USER- ACL LABS - STATES THAT WHEN A NURSE WAS ATTEMPTING TO TAKE A SPECIMEN FOR STTH FROM A CHILD, HE/SHE BIT DOWN ON THE SHAFT OF THE SWAB AND THE SWAB THEN BECAME LODGED IN THE THROAT." ON OCTOBER 25TH, 2016 WE ASKED FOR MORE INFORMATION THROUGH A QUESTIONNAIRE. ON OCTOBER 31ST, 2016 WE RECEIVED THE QUESTIONNAIRE FILLED IN BY A NURSE PRACTITIONER PRESENT AT THE TIME OF THE EVENT. THE FOLLOWING DETAILS HAVE BEEN REPORTED: NO REPORT WAS SENT BY THE HOSPITAL TO FDA. TEST PERFORMED WAS A STREP A. IT WAS REPORTED THAT PATIENT WAS NERVOUS, BUT FULLY COOPERATIVE WITH OPENING HIS MOUTH. PROVIDER DID NOT HAVE TO FORCE HIS MOUTH OPEN. PATIENT WAS NOT SEDATED DURING COLLECTION. THE EVENT DESCRIPTION PROVIDED WAS THE FOLLOWING: "(B)(6) CHILD WAS SITTING ON HIS MOM'S LAP IN THE CHAIR BECAUSE CHILD WAS TOO FEARFUL TO SIT ON EXAM TABLE FOR STREP SWAB (CHILD WAS RELUCTANT TO HAVE SWAB PERFORMED, BUT WAS COOPERATIVE IN THE END.) CHILD OPENED HIS MOUTH AND AS PROVIDER WAS REMOVING THE CULTURE SWAB FROM HIS MOUTH, CHILD JERKED HIS HEAD AND BIT DOWN ON THE SWAB AT THE RED LINE WHICH CRACKED OFF PREMATURELY LEAVING THE FRONT HALF OF THE SWAB AND STICK BELOW THE RED LINE INSIDE THE CHILD'S MOUTH/THROAT. PROVIDER WAS ABLE TO REMOVE THE SWAB IMMEDIATELY WITHOUT ANY INJURY TO THE CHILD. THE CULTURE WAS THEN SENT TO LAB FOR PROCESSING." ON NOVEMBER 2ND, 2016 WE RECEIVED ADDITIONAL INFORMATION: "THE NURSE PERFORMED THE ESWAB AND BACTISWAB AT THE SAME TIME AND SAID THE CHILD WAS FRIGHTENED AND BIT DOWN ON THE SWAB NEAR THE RED BREAK LINE CAUSING THE ESWAB TO SNAP IN TWO RESULTING IN THE SWAB GETTING LODGED IN HIS THROAT". BACTISWAB IS NOT MANUFACTURED BY COPAN. WE ASKED FOR MORE DETAILS AND ON NOVEMBER 9TH, 2016 WE RECEIVED THE INFORMATION THAT THE COLLECTION WAS PERFORMED AT THE SAME TIME USING TWO DIFFERENT SWABS (ONE OF THE ESWAB AND ONE OF THE BACTISWAB) IN THE SAME COLLECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760950 ESWAB TRANSPORT CULTURE MEDIUM DEVICE JTW COPAN ITALIA SPA 480C 4QN700

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention