BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 18005755 · Received October 25, 2023

    Report

    Report Number
    3008007472-2023-00043
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 28, 2023
    Report Date
    January 22, 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 SIXTEEN (16) VIALS WITH BROKEN CAPS (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 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 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 (B)(4) KITS (B)(4) VIALS) WERE PRODUCED AND WERE INSPECTION USING ANSI GENERAL LEVEL II, SINGLE SAMPLING, NORMAL, AT AN AQL OF 0.65%. A TOTAL OF (B)(4) VIALS WERE QC INSPECTED PRIOR TO PRODUCT DISPOSITION WITH A TOTAL OF 0 DEFECTS OBSERVED. AN ADDITIONAL (B)(4) 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. 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 3017888 IDENTIFIED 800 CAPS WERE INSPECTED FROM EACH LOT AND PASSED THE ACCEPTANCE CRITERIA WITH ZERO DEFECTS IDENTIFIED. A SAMPLE WAS NOT RETURNED TO THE MEBANE, NC FACILITY FOR EVALUATION. ALTHOUGH PICTURES WERE PROVIDED, THE PICTURES DID NOT CONTAIN ANY VIALS WITH THE COMPLAINT DEFECT. 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. THE COMPLAINT IS NOT CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1 INITIAL REPORTER ADDR 1:(B)(6). H.3. 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

    PATIENT 3 OF 16. IT WAS REPORTED THAT WHILE USING THE VIAL SUREPATH COLLECTION KIT 500 THAT THE SURE PATH COLLECTION VIAL CONTAINING PATIENT SAMPLE CRACKED. 16 PATIENTS WERE AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER WHILE PROCESSING, ALL THE VIALS CORRESPONDING TO LOT 3060223 BROKE. THEY CAME FROM THE CLINIC. BROKEN CAPS OF SAMPLE VIALS.- COULD YOU CONFIRM THE AFFECTED NUMBER OF VIALS WITH BROKEN CAPS? 16.

    Description of Event or Problem · 0

    PATIENT 3 OF 16. IT WAS REPORTED THAT WHILE USING THE VIAL SUREPATH COLLECTION KIT 500 THAT THE SURE PATH COLLECTION VIAL CONTAINING PATIENT SAMPLE CRACKED. 16 PATIENTS WERE AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. WHILE PROCESSING, ALL THE VIALS CORRESPONDING TO LOT 3060223 BROKE. THEY CAME FROM THE CLINIC. BROKEN CAPS OF SAMPLE VIALS.- COULD YOU CONFIRM THE AFFECTED NUMBER OF VIALS WITH BROKEN CAPS? 16.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047745 VIAL SUREPATH COLLECTION KIT 500 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 3060223 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown