BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 19524715 · Received June 12, 2024

    Report

    Report Number
    3008007472-2024-00010
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 14, 2024
    Report Date
    May 17, 2024
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    UDI-DI
    10382904914520
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT IS FOR ONE (1) VIAL OF 491452 LOT NUMBER 2229702 THAT WAS EMPTY AND NOT ABLE TO BE RECLOSED. A 12-MONTH COMPLAINT REVIEW WAS PERFORMED. THERE HAVE BEEN PREVIOUS COMPLAINTS AGAINST 491452 FOR LEAKAGE AND PREVIOUS COMPLAINTS AGAINST LOT 2229702. BD PERFORMS REGULAR TRENDING TO DETERMINE IF A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) IS REQUIRED, AND AS OF THIS TIME THE THRESHOLD FOR A CAPA HAS NOT BEEN REACHED. BD WILL CONTINUE TO MONITOR AND EVALUATE TRENDS. MATERIAL 491452 IS MANUFACTURED AT THE BD MEBANE, NC FACILITY ON A VALIDATED AUTOMATED FILLING LINE REFERRED TO AS THE SHIBUYA VIAL FILLING LINE. THE REVIEW OF THE MANUFACTURING DHR FOR LOT NUMBER 2229702 IDENTIFIED THAT MANUFACTURING BEGAN ON 19AUG2022 AND A TOTAL OF (B)(4) KITS WERE PRODUCED WITH NO ISSUES OBSERVED. DURING THE PRODUCTION PROCESS, A TOTAL OF (B)(4) VIALS WERE SUBJECT TO LEAK TESTING UNDER VACUUM WITH NO LEAKING VIALS OR CRACKED CAPS OBSERVED. AN ANALYSIS OF THE RETAINS WAS PERFORMED AND DID NOT IDENTIFY ANY CRACKS, LEAKS, OR OTHER ABNORMALITIES. NO PICTURES WERE PROVIDED, AND NO SAMPLES WERE RETURNED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    REPORT 1 OF 2. IT WAS REPORTED WHEN USING THE VIAL SUREPATH COLLECTION KIT 500, THE SAMPLES LEAKED OUT OF THE VIAL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372591 VIAL SUREPATH COLLECTION KIT 500 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 2229702 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown