BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 18519261 · Received January 16, 2024

    Report

    Report Number
    3008007472-2024-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    September 21, 2023
    Report Date
    February 20, 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

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR ONE (1) VIAL WITH A BROKEN CAP (POST SAMPLE COLLECTION) FROM ITEM 491452 LOT NUMBER 3060223. MATERIAL 491452 IS PRODUCED AT THE BD MEBANE, NC FACILITY ON A VALIDATED AUTOMATED MANUFACTURING LINE. THE CAPPER SECTION CAPS THE VIALS TO A VALIDATED APPLICATION TORQUE. 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. THE PM IS PERFORMED BY USING A CALIBRATED TORQUE VERIFIER THAT IS COMPARED AGAINST THE APPLICATION TORQUE VALUE. PRODUCTION OF MATERIAL 491452 LOT 3060223 STARTED ON 07MAR2023. 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 800 VIALS WERE QC INSPECTED PRIOR TO PRODUCT DISPOSITION WITH A TOTAL OF 0 DEFECTS OBSERVED. AN ADDITIONAL 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 ABNORMAL ACTIVITIES DURING MANUFACTURING. THE REVIEW OF THE BILL OF MATERIALS (BOM) FOR 491452 LOT 3060223 IDENTIFIED THAT RAW CAP LOT NUMBER MATERIAL 700030951 LOT NUMBER 3017888 WAS USED DURING THE PRODUCTION. A REVIEW OF THE INCOMING INSPECTION RESULTS FOR 700030951 LOT NUMBER 3017888 IDENTIFIED 800 CAPS WERE INSPECTED FROM THE LOT AND PASSED THE ACCEPTANCE CRITERIA WITH ZERO DEFECTS IDENTIFIED. A SAMPLE WAS NOT RETURNED TO THE FACILITY FOR EVALUATION. A VISUAL RETAIN ANALYSIS WAS PERFORMED ON ONE CLAMSHELL (25 VIALS) FROM ITEM 491452 LOT 3060223. NO CRACKED/BROKEN CAPS WERE IDENTIFIED DURING THE RETAIN ANALYSIS. A PICTURE WAS PROVIDED THAT SHOWS A CRACKED CAP. THE COMPLAINT IS CONFIRMED. A 12-MONTH COMPLAINT REVIEW FOR THE DEFECT MODE OF BROKEN CAPS WAS PERFORMED AND IDENTIFIED PREVIOUS COMPLAINTS FOR THE ITEM NUMBER AND A PREVIOUS BROKEN CAP COMPLAINT FOR 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.

    Additional Manufacturer Narrative · 0

    G.4: DATE RECEIVED BY MANUFACTURER HAS BEEN CORRECTED TO 26DEC2023.

    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 WHEN USING THE VIAL SUREPATH COLLECTION KIT 500 THE VIAL CAP ARRIVED CRACKED CONTAINING PATIENT SAMPLE CAUSING THE SAMPLE TO LEAK. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE VIAL SUREPATH COLLECTION KIT 500 THE VIAL CAP ARRIVED CRACKED CONTAINING PATIENT SAMPLE CAUSING THE SAMPLE TO LEAK. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE VIAL SUREPATH COLLECTION KIT 500 THE VIAL CAP ARRIVED CRACKED CONTAINING PATIENT SAMPLE CAUSING THE SAMPLE TO LEAK. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854305 VIAL SUREPATH COLLECTION KIT 500 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 3060223 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female