BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT

    MDR report key: 19951866 · Received August 9, 2024

    Report

    Report Number
    2024800-2024-00011
    Event Type
    Injury
    Date Received
    August 9, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 9, 2024
    Manufacturer
    HOLOGIC, INC.
    Product Code
    LIO
    UDI-DI
    25420045506272
    PMA / PMN Number
    K032554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HOLOGIC COMPLETED A RETENTION CHECK USING THE RETAINED LOT NUMBER 880984V OF APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT. PRESSURE WAS APPLIED TO THE TIP IN VARIOUS DIRECTIONS TO SIMULATE POTENTIAL STRESS PLACED ON THE SWAB DURING SAMPLE COLLECTION. THE TIP WAS ABLE TO WITHSTAND A CONSIDERABLE AMOUNT OF FORCE AND BEND IN VARIOUS DIRECTIONS BEFORE ANY PLASTIC DEFORMATION/FRAY WAS OBSERVED. A PREVIOUS EVENT SEARCH FOR APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT LOT NUMBER 880984V AND SWAB LOT NUMBERS LN: 882799 AND LN: 884783 SHOWED THAT AS OF 07/25/2024, THERE WERE NO SIMILAR COMPLAINTS ASSOCIATED WITH THIS LOT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, CONFIRMING THAT THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS. HOLOGIC COMPLETED A RISK ASSESSMENT. THE PATIENT WAS IMPACTED AS THE COLLECTION KIT SWAB BROKE AND BECAME LODGED IN THEIR CERVIX WHICH REQUIRED REMOVAL BY THE PHYSICIAN. HOWEVER, THERE WAS NO HARM OR SUBSEQUENT INJURY REPORTED. INVESTIGATION INTO THIS ISSUE IS CURRENTLY IN PROCESS WITH THE SWAB MANUFACTURER.

    Description of Event or Problem · 0

    ON 07/23/24, A CUSTOMER CONTACTED HOLOGIC TO REPORT A BROKEN SWAB TIP THAT OCCURRED DURING SPECIMEN COLLECTION ON 07/19/24 USING THE APTIMA UNISEX SWAB SPECIMEN COLLECTION KIT, LOT NUMBER 880984V. ACCORDING TO THE CUSTOMER, APPROXIMATELY 1 CM OF THE SWAB TIP BROKE INSIDE THE CERVIX. THE TIP OF THE SWAB WAS SAFELY REMOVED BY THE PHYSICIAN WITH TWEEZERS AND NO INJURIES WERE REPORTED. NO ADDITIONAL TREATMENT WAS NEEDED. HOLOGIC IS REPORTING THIS INCIDENT BECAUSE A MEDICAL INTERVENTION WAS REQUIRED TO PREVENT TEMPORARY OR PERMANENT IMPAIRMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514709 APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT DEVICE, SPECIMEN COLLECTION LIO HOLOGIC, INC. 880984V 25420045506272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention