BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 17593248 · Received August 22, 2023

    Report

    Report Number
    3008007472-2023-00022
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    August 8, 2023
    Report Date
    November 16, 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

    H.6. INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR VIALS WITH BROKEN CAPS FOR MATERIAL 491452 LOT NUMBER 3010747. THE INVESTIGATION CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORDS FROM PRODUCTION, RETAIN ANALYSIS, CUSTOMER RETURN ANALYSIS AND RELATED CUSTOMER COMPLAINT TRENDING. THE REVIEW OF THE MANUFACTURING BATCH RECORDS FOR MATERIAL 491452 LOT 3010747 IDENTIFIED THAT IT WAS COMPLETE AND ACCURATE WITH NO INDICATION OF ANY ISSUES OR ABNORMAL ACTIVITIES DURING THE PRODUCTION OF THE LOT. THERE WERE ZERO DEFECTS OBSERVED DURING THE INSPECTION OF THE CAPS USED IN THE PRODUCTION OF MATERIAL 491452 LOT 3010747. A VISUAL RETAIN ANALYSIS WAS PERFORMED ON ONE CLAMSHELL (25 VIALS) FROM MATERIAL 491452 LOT 3010747. THE COMPLAINT MODE WAS NOT IDENTIFIED DURING RETAIN ANALYSIS. A RETURNED SAMPLE WAS NOT AVAILABLE SO NO FORMAL INSPECTION COULD BE PERFORMED. HOWEVER, PICTURES WERE PROVIDED THAT SHOW THE CRACKED CAP. THEREFORE, THE COMPLAINT IS CONFIRMED. A 12-MONTH COMPLAINT REVIEW FOR THE DEFECT MODE OF CRACKED CAP AND EMPTY VIAL WAS PERFORMED AND IDENTIFIED PREVIOUS COMPLAINTS FOR THE ITEM NUMBER BUT NO PREVIOUS COMPLAINTS FOR LOT 3010747. BD PERFORMS REGULAR TRENDING AND AS OF THIS TIME THE THRESHOLD FOR A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS NOT BEEN REACHED. BD WILL CONTINUE TO MONITOR AND EVALUATE TRENDS.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER ADDR 1: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 2 OF 3. IT WAS REPORTED THAT WHILE USING VIAL SUREPATH COLLECTION KIT 500, THERE WAS A CRACKED CAP OF A VIAL CONTAINING A PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VIAL CAPS CRACK. THE CLIENT REPORTS: CURRENTLY THERE ARE TWO NEW INCIDENTS IN THE GUADALAJARA AREA WHERE THEY REPORT 3 DAMAGED ROADS. 2 VIALS WERE REDUCED TO BE ABLE TO CARRY OUT A CORRECT SEALING OF THE SAMPLE AND NOT AFFECT THE PATIENTS WITH THEIR RESULTS. LOT NO. 3010747, 2300761 (FIGURES 1 AND 2)."

    Description of Event or Problem · 0

    REPORT 2 OF 3. IT WAS REPORTED THAT WHILE USING VIAL SUREPATH COLLECTION KIT 500, THERE WAS A CRACKED CAP OF A VIAL CONTAINING A PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VIAL CAPS CRACK. THE CLIENT REPORTS: CURRENTLY THERE ARE TWO NEW INCIDENTS IN THE GUADALAJARA AREA WHERE THEY REPORT 3 DAMAGED ROADS. 2 VIALS WERE REDUCED TO BE ABLE TO CARRY OUT A CORRECT SEALING OF THE SAMPLE AND NOT AFFECT THE PATIENTS WITH THEIR RESULTS. LOT NO. 3010747, 2300761 (FIGURES 1 AND 2)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2167300 VIAL SUREPATH COLLECTION KIT 500 PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED MKQ TRIPATH IMAGING, INC 3010747 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 Female