BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 19235714 · Received May 2, 2024

    Report

    Report Number
    3008007472-2024-00007
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 5, 2024
    Report Date
    June 6, 2024
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    UDI-DI
    10382904914520
    PMA / PMN Number
    P970018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR EXPOSURE TO PRESERVATIVE FLUID FROM 491452 LOT NUMBER 3143770. THE CUSTOMER STATED THAT A VIAL WAS SPILLED PRIOR TO SAMPLE COLLECTION. WHILE ATTEMPTING TO CLEAN UP THE SPILLED VIAL, THE CUSTOMER'S HAND CAME INTO DIRECT CONTACT WITH PRESERVATIVE FLUID DUE TO NOT WEARING APPROPRIATE PPE (PERSONAL PROTECTIVE EQUIPMENT). A 12-MONTH COMPLAINT REVIEW WAS PERFORMED FOR THE ITEM NUMBER AND LOT NUMBER. NO PREVIOUS COMPLAINTS FOR THE DEFECT MODE WERE IDENTIFIED. COMPLAINTS ARE TRENDED AT THE (B)(4), NC FACILITY AND TRIGGER LEVELS PER THE PROCEDURE HAVE NOT BEEN MET, THEREFORE, NO CAPA INITIATION DETERMINATION (CID) OR CORRECTIVE OR PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED FOR THE ISSUE. BD QUALITY WILL CONTINUE TO MONITOR AND TREND EVENTS RELATED TO THIS ISSUE TO DETERMINE IF CORRECTIVE ACTIONS ARE REQUIRED. MATERIAL 491452 IS MANUFACTURED AT THE (B)(4) NC FACILITY ON A VALIDATED AUTOMATED FILLING LINE. THE REVIEW OF THE MANUFACTURING DHR FOR THE LOT NUMBER IDENTIFIED THAT IT WAS COMPLETE AND ACCURATE DURING PRODUCTION AT THE (B)(4), NC FACILITY. DURING THE PRODUCTION PROCESS, A TOTAL OF (B)(4) VIALS WERE SUBJECT TO LEAK TESTING UNDER VACUUM. NO LEAKING VIALS WERE OBSERVED. A REVIEW OF THE PRODUCT INSERT AND SAFETY DATA SHEET IDENTIFIED THAT USERS ARE INSTRUCTED TO WEAR PROTECTIVE GLOVES, PROTECTIVE CLOTHING, EYE PROTECTION AND FACE PROTECTION. AN ANALYSIS OF THE RETAIN WAS PERFORMED AND DID NOT IDENTIFY ANY LEAKS OR ABNORMALITIES. NO SAMPLE WAS RETURNED, AND PICTURES WERE NOT PROVIDED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VIAL SUREPATH COLLECTION KIT 500 SPILLED IN A DRAWER. THE VIAL PRESERVATIVE FLUID WAS BEING CLEANED UP, WHEN THE USER NOTICED AN ITCHING SENSATION ON THEIR HANDS AND AN IRRITATION TO THEIR EYES AND NOSE DUE TO THE SMELL. THE USER IMMEDIATELY WASHED THEIR HANDS. NO MEDICAL INTERVENTION WAS NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VIAL SUREPATH COLLECTION KIT 500 SPILLED IN A DRAWER. THE VIAL PRESERVATIVE FLUID WAS BEING CLEANED UP, WHEN THE USER NOTICED AN ITCHING SENSATION ON THEIR HANDS AND AN IRRITATION TO THEIR EYES AND NOSE DUE TO THE SMELL. THE USER IMMEDIATELY WASHED THEIR HANDS. NO MEDICAL INTERVENTION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919659 VIAL SUREPATH COLLECTION KIT 500 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 3143770 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other