BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BINAXNOW

    MDR report key: 1990658 · Received February 8, 2011

    Report

    Report Number
    1221359-2011-00001
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 10, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ALERE SCARBOROUGH, INC.
    Product Code
    GNX
    PMA / PMN Number
    K053126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT# 2363. ADDITIONAL EXP DATE: 11/30/2014. THE NASOPHARYNGEAL SWAB IS INCLUDED AS A COMPONENT OF THE BINAXNOW INFLUENZA A & B TEST KIT. THE SWAB IS A PACKAGED COMPONENT PURCHASED FORM (B)(4). PURITAN WAS CONTACTED AND INFORMED OF THIS ADVERSE EVENT. THE SAMPLE WAS RETURNED TO PURITAN MEDICAL PRODUCTS (B)(4), MANUFACTURER OF THE SWAB. THE FOLLOWING WAS RECEIVED FROM PURITAN. (B)(4). BATCH RECORDS WERE REVIEWED AS WELL AS RETENTION SAMPLES PULLED FOR EVALUATION. NO DEFECTIVE OR ANOMALIES WERE DISCOVERED. BASED ON SAMPLES EXAMINED, SHAFTS DO NOT FRACTURE UNLESS BENT REPEATEDLY. IT IS BELIEVED THE END USER MANIPULATED THE SWAB PRIOR TO IT ENTERING THE NASAL PASSAGE. (B)(4). IT IS DETERMINED THAT THIS IS AN ISOLATED EVENT GIVEN THE HISTORICAL EVIDENCE OF THE CLAIM, THE EVALUATION OF THE SAMPLES. THIS IS AN EXTRAORDINARILY RARE INCIDENCE.

    Description of Event or Problem · 1

    WHEN COLLECTION A NASOPHARYNGEAL SAMPLE FOR THE BINAXNOW INFLUENZA A&B TEST KIT, THE PLASTIC SHAFT OF THE COLLECTION SWAB PROVIDED IN THE KIT BROKE WHERE THE FOAM AND SHAFT MEET. THE PLASTIC SHAFT AND FOAM WERE LODGED IN THE PT'S NASAL PASSAGE, AND THE DOCTOR NOTED THAT THE PT SNIFFED WHILE THE SAMPLE WAS BEING COLLECTED. THE PARENTS REFUSED ANY INTERVENTION FOR REMOVAL OF TIP. THEY WERE NOT INTERESTED IN GOING TO THE EMERGENCY ROOM. THE DOCTOR FOLLOWED UP WITH THE PARENTS ON (B)(6) 2011 AND (B)(6) 2011 AND THE CHILD WAS NOT UNCOMFORTABLE AND THE PARENTS STILL DO NOT WANT ANY FURTHER INVESTIGATIONS PERFORMED ON CHILD TO RETRIEVE SWAB TIP. THE DOCTOR IS HOPING THAT THE CHILD SWALLOWED THE TIP AND PASSED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BINAXNOW INFLUENZA A&B CLIA WAIVED 22 TEST KIT GNX ALERE SCARBOROUGH, INC. 042827 OR 043170

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other