BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 18615954 · Received January 31, 2024

    Report

    Report Number
    3008007472-2024-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    October 18, 2023
    Report Date
    May 8, 2024
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    UDI-DI
    10382904914520
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B5: IT WAS REPORTED THAT DURING USE WITH THE VIAL SUREPATH COLLECTION KIT 500, A VIAL CONTAINING PATIENT SAMPLE HAD A CRACKED CAP. THE SAMPLE HAS TO BE RECOLLECTED. H.6. INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR ONE (1) VIAL WITH A CRACKED CAP FROM ITEM 491452 LOT NUMBER 2229702. MATERIAL 491452 IS PRODUCED AT THE BD MEBANE, NC FACILITY ON A VALIDATED AUTOMATED MANUFACTURING LINE. THE CAPPER IS VALIDATED TO INSPECT FOR APPLICATION TORQUE AND UNSEATED OR MISSING CAPS. VIALS THAT FAIL TO MEET INSPECTION REQUIREMENTS (I.E., OUTSIDE OF THE VALIDATED APPLICATION TORQUE) ARE REJECTED AUTOMATICALLY AFTER THE CAPPER SECTION. TO ENSURE THAT THE CAPPER REMAINS IN VALIDATED STATE, A QUARTERLY PREVENTIVE MAINTENANCE (PM) IS ESTABLISHED THAT IS USED TO CONFIRM ACCURACY OF APPLICATION TORQUE FOR EACH OF THE CAPPER HEADS. A REVIEW OF THE TWO (2) PM EVENTS THAT BRACKETED THE PRODUCTION DATE IDENTIFIED THAT THE RESULTS OF THE VERIFICATION WERE ACCEPTABLE. A TOTAL OF (B)(4) KITS ((B)(4) VIALS) WERE PRODUCED. A TOTAL OF 800 VIALS WERE LEAK TESTED IN A VACUUM CHAMBER DURING IN-PROCESS TESTING AND DID NOT IDENTIFY ANY LEAKING OR CRACKED CAP DEFECTS. THE REVIEW OF THE MANUFACTURING DHR FOR THE LOT NUMBER IDENTIFIED THAT IT WAS COMPLETE AND ACCURATE WITH NO INDICATION OF ABNORMALITIES DURING MANUFACTURING. THE REVIEW OF THE BILL OF MATERIALS (BOM) FOR 491452 LOT 2229702 IDENTIFIED THAT RAW CAP MATERIAL 700030951 LOT NUMBER 2152139 WAS USED DURING THE PRODUCTION. A REVIEW OF THE INCOMING INSPECTION RESULTS FOR 700030951 LOT NUMBER 2152139 IDENTIFIED 800 CAPS WERE INSPECTED FROM THE LOT AND PASSED THE ACCEPTANCE CRITERIA WITH ZERO DEFECTS IDENTIFIED. A VISUAL RETAIN ANALYSIS WAS PERFORMED ON ONE CLAMSHELL (25 VIALS) FROM ITEM 491452 LOT 2229702. NO CRACKED CAPS WERE IDENTIFIED DURING THE RETAIN ANALYSIS. A SAMPLE WAS NOT RETURNED BUT A PICTURE WAS PROVIDED THAT SHOWED A CRACKED CAP. THE COMPLAINT IS CONFIRMED. A 12-MONTH COMPLAINT REVIEW FOR THE DEFECT MODE OF CRACKED CAPS WAS PERFORMED AND IDENTIFIED PREVIOUS COMPLAINTS FOR THE ITEM NUMBER BUT NOT THE LOT NUMBER. 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. H3 OTHER TEXT: SEE H.10.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDRESS: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE VIAL SUREPATH COLLECTION KIT 500, A VIAL CONTAINING PATIENT SAMPLE HAD A CRACKED CAP. THE SAMPLE HAS TO BE RECOLLECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE VIAL SUREPATH COLLECTION KIT 500, A VIAL CONTAINING PATIENT SAMPLE HAD A CRACKED CAP. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383543 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