BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 17572891 · Received August 18, 2023

    Report

    Report Number
    3008007472-2023-00016
    Event Type
    Malfunction
    Date Received
    August 18, 2023
    Date of Event
    July 27, 2023
    Report Date
    December 11, 2023
    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

    E6: INITIAL REPORTER E-MAIL: (B)(6). E7: INITIAL REPORTER ADDR 1: (B)(6). H3: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO B5: REPORT 8 OF 9. IT WAS REPORTED THAT WHILE USING VIAL SUREPATH COLLECTION KIT 500 THAT THERE WAS A VIAL CRACKED THAT CONTAINED A PATIENT SAMPLE. H6. INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR THREE (3) INSTANCES IN THE PREVIOUS THREE (3) MONTHS OF CRACKED CAPS ON VIALS CAUSING SAMPLE LEAKAGE (POST SAMPLE COLLECTION) FROM ITEM 491452 LOT NUMBER 2304652. MATERIAL 491452 IS PRODUCED AT THE BD MEBANE, NC FACILITY ON A VALIDATED AUTOMATED MANUFACTURING LINE REFERRED TO AS THE SHIBUYA VIAL FILLING LINE. THE CAPPER SECTION OF THE SHIBUYA VIAL FILLING LINE CONTAINS EIGHT (8) CAPPER HEADS, WHICH CAPS THE VIALS TO A VALIDATED APPLICATION TORQUE CONTROLLED BY SERVO MOTOR. 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 EIGHT (8) HEADS. THE PM IS PERFORMED BY USING A CALIBRATED SERVO TORQUE VERIFIER THAT IS COMPARED AGAINST THE SHIBUYA CAP APPLICATION TORQUE VALUE. PRODUCTION OF MATERIAL 491452 LOT 2304652 STARTED ON (B)(6) 2022. A REVIEW OF THE TWO (2) PM EVENTS THAT BRACKETED THE PRODUCTION DATE IDENTIFIED THAT THE RESULTS OF THE VERIFICATION WERE ACCEPTABLE. FURTHER REVIEW IDENTIFIED THAT THERE HAS NEVER BEEN A FAILURE OF THE SERVO TORQUE VERIFICATION PM EVENTS. A REVIEW OF THE MAINTENANCE HISTORY ON THE CAPPER IDENTIFIED NO EQUIPMENT REPAIRS THAT COULD BE CORRELATED TO THE COMPLAINT EVENT. A TOTAL OF 432 KITS (216,000 VIALS) WERE PRODUCED AND WERE INSPECTION USING ANSI GENERAL LEVEL II, SINGLE SAMPLING, NORMAL, AT AN AQL OF 0.65%. 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 IDENTIFIED 1 LEAKING OR CRACKED CAP DEFECTS. THE DHR DID NOT CONTAIN CLARIFICATION IF A CRACKED CAP CONTRIBUTED TO THE LEAKING VIAL. 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 2304652 IDENTIFIED THAT RAW CAP LOT NUMBER MATERIAL 700030951 LOT NUMBER 2222109 WAS USED DURING THE PRODUCTION. RAW CAP ITEM NUMBER 700030951 IS INSPECTED USING ANSI GENERAL LEVEL II, SINGLE SAMPLING, NORMAL, AT AN AQL OF 0.65%. A REVIEW OF THE INCOMING INSPECTION RESULTS FOR 700030951 LOT NUMBER 2222109 IDENTIFIED 800 CAPS WERE INSPECTED FROM EACH 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 2304652. NO CRACKED CAPS WERE IDENTIFIED DURING THE RETAIN ANALYSIS. A SAMPLE WAS NOT RETURNED TO THE MEBANE, NC FACILITY FOR EVALUATION. HOWEVER, MULTIPLE PICTURES WERE PROVIDED THAT CONFIRM VIALS WITH CRACKED CAPS. THE CRACKS ARE HORIZONTAL CRACKS AT THE NEAR THE TOP OF THE CAP (NEAR LOCATION OF THREAD RUN OUT). THEREFORE, THE COMPLAINT IS CONFIRMED. A 12-MONTH COMPLAINT REVIEW FOR THE DEFECT MODE OF CRACKED CAP WAS PERFORMED AND IDENTIFIED PREVIOUS COMPLAINTS FOR THE ITEM NUMBER BUT NO PREVIOUS CRACKED CAP COMPLAINTS FOR THE LOT NUMBER. BD WILL CONTINUE TO MONITOR AND EVALUATE TRENDS.

    Description of Event or Problem · 0

    REPORT 8 OF 9. IT WAS REPORTED THAT WHILE USING VIAL SUREPATH COLLECTION KIT 500 THAT THERE WAS A VIAL CRACKED THAT CONTINUED A PATIENT SAMPLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE INCIDENT NOTED BEFORE, DURING OR AFTER THE USE OF THE REAGENT? AFTER IF THE VIALS WERE USED, WERE THERE ANY LOSS OF PATIENT SAMPLES? YES , DUE TO THE REPORTED BROKEN CAP DEFECT CAUSE A LEAK AND THE LEAKING AFFECT THE IDENTIFICATION LABEL OF 9 PATIENT SAMPLES, NEW SAMPLES WERE TAKEN, AND RESULTS WERE DELAYED. IF SO, WAS IT NECESSARY TO TAKE NEW SAMPLES FROM THE PATIENTS? YES WAS THERE A DELAY IN THE DIAGNOSIS OF THE PATIENTS? YES THE CAP BROKE FROM THE UPPER PART, ON OTHER OCCASIONS THEY ONLY SPILL, I AM ALSO REVIEWING THIS ISSUE WITH LOGISTICS, THE VIALS ARE FROM LOT: 2304652.

    Description of Event or Problem · 0

    REPORT 8 OF 9. IT WAS REPORTED THAT WHILE USING VIAL SUREPATH COLLECTION KIT 500 THAT THERE WAS A VIAL CRACKED THAT CONTAINED A PATIENT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171875 VIAL SUREPATH COLLECTION KIT 500 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 2304652 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown