BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE CLEANWIPE FOAM SWAB

    MDR report key: 10676738 · Received October 13, 2020

    Report

    Report Number
    MW5097197
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 9, 2020
    Manufacturer
    FOAMTEC INTERNATIONAL CO., LTD.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOAM COATING AT THE TIP OF SWAB USED FOR COVID-19 TESTING CAME OFF OF THE SWAB SHAFT WHILE IN PATIENT'S NOSE. PATIENT USED NASAL SALINE LAVAGE TO SUCCESSFULLY REMOVE THE FOAM TIP. SEVERAL SWABS FROM THE SAME MANUFACTURER AND LOT NUMBER WERE DEFECTIVE, WITH FOAM TIP COMING OFF PRIOR TO USE IN PATIENTS. WE TESTED 100 SWABS FROM THE SAME LOT NUMBER TO SEE IF THE TIPS WERE EASILY REMOVED WITH LIGHT PRESSURE. NINE OF 100 WERE DEFECTIVE BY THIS TECHNIQUE. SWABS ARE FROM FOAMTEC INTERNATIONAL, PRODUCT #MP1301AST, LOT #0640202040. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134279 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134282 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134283 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134284 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134285 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134286 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134287 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134288 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040
    1134289 STERILE CLEANWIPE FOAM SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG FOAMTEC INTERNATIONAL CO., LTD. 0640202040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other