BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL SUREPATH COLLECTION KIT 500

    MDR report key: 16781339 · Received April 20, 2023

    Report

    Report Number
    3008007472-2023-00003
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 27, 2023
    Report Date
    July 20, 2023
    Manufacturer
    TRIPATH IMAGING, INC
    Product Code
    MKQ
    UDI-DI
    10382904914520
    PMA / PMN Number
    P970018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THE CUSTOMER COMPLAINT IS FOR TWO (2) LEAKING VIALS OF 491452 LOT NUMBER 2160256. UPON CLOSER INSPECTION OF THE LEAKING VIALS, IT WAS NOTICED THAT THE CAP CONTAINED A TINY CRACK. A 12-MONTH COMPLAINT REVIEW WAS PERFORMED AND ALTHOUGH THERE HAVE BEEN PREVIOUS COMPLAINTS AGAINST 491452 FOR LEAKAGE, THERE ARE NO PREVIOUS COMPLAINTS AGAINST LOT 2160256. COMPLAINTS ARE TRENDED AT THE MEBANE, NC FACILITY AND TRIGGER LEVELS PER THE PROCEDURE HAVE NOT BEEN MET. THEREFORE, NO CAPA INITIATION DETERMINATION (CID) OR CORRECTIVE OR PREVENTATIVE ACTION (CAPA) HAS BEEN INITIATED FOR THE ISSUE. BD QUALITY WILL CONTINUE TO MONITOR AND TREND EVENTS RELATED TO THIS ISSUE TO DETERMINE IF CORRECTIVE ACTIONS ARE REQUIRED. MATERIAL 491452 IS MANUFACTURED AT THE BD MEBANE, NC FACILITY ON A VALIDATED AUTOMATED FILLING LINE REFERRED TO AS THE SHIBUYA VIAL FILLING LINE. THE REVIEW OF THE MANUFACTURING DHR FOR LOT NUMBER 2160256 IDENTIFIED THAT IT WAS COMPLETE AND ACCURATE WITH NO ISSUES OBSERVED. DURING THE PRODUCTION PROCESS, A TOTAL OF 800 VIALS WERE SUBJECT TO LEAK TESTING UNDER VACUUM WITH NO LEAKING VIALS WERE OBSERVED. A REVIEW OF THE BILL OF MATERIALS (BOM) IDENTIFIED THAT ONE LOT NUMBER OF CAPS WERE USED DURING PRODUCT OF LOT 2160256, LOT 22-TM-259. A REVIEW OF THE INCOMING INSPECTION DOCUMENTATION FOR CAP LOT NUMBER 22-TM-259 IDENTIFIED THAT 800 CAPS WERE SUBJECTED TO ACCELERATED AGING TESTING AND THAT ZERO CRACKED CAPS WERE IDENTIFIED DURING TESTING. AN ANALYSIS OF THE RETAINS WAS PERFORMED AND DID NOT IDENTIFY ANY CRACKS, LEAKS, OR OTHER ABNORMALITIES. A PICTURE OF THE VIALS WAS PROVIDED WHICH SHOWS WHAT APPEARS TO BE A SMALL CRACK ON ONE OF THE VIALS AND THE COMPLAINT IS CONFIRMED, ALTHOUGH NO LEAKAGE IS OBSERVED IN THE PICTURE. THE VIALS WERE NOT RETURNED TO MEBANE SO A CLOSER EVALUATION COULD NOT BE PERFORMED. BD APOLOGIZES FOR THE INCONVENIENCE CAUSED BY THE ISSUE AND WILL CONTINUE TO MONITOR AND TREND EVENTS RELATED TO THIS ISSUE TO DETERMINE IF CORRECTIVE ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    E.7 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

    IT WAS REPORTED THAT WHILE USING THE VIAL SUREPATH COLLECTION KIT 500 THAT THERE WAS A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TINY CRACK WAS FOUND ON THE LIP CAP OF SUREPATH VIALS, LIQUID INSIDE WAS FOUND TO BE LEAKED. 1) DID THE VIAL CONTAIN PATIENT SAMPLE OR WAS THIS NOTICED PRIOR TO USE? YES, THE LAB OPERATOR FOUND THE LEAKAGE WHEN RECEIVING RETURNED VIALS FROM CLINIC. 2) IF IT CONTAINED PATIENT SAMPLE DID THE SAMPLE NEED TO BE RECOLLECTED? NO NEED, BECAUSE THE VIALS WERE PACKED INTO INDIVIDUAL SPECIMEN BAG AND THE LEAKAGE WERE TINY, NO RISK OF CONTAMINATION JUDGED BY THE OPERATOR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE VIAL SUREPATH COLLECTION KIT 500 THAT THERE WAS A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TINY CRACK WAS FOUND ON THE LIP CAP OF SUREPATH VIALS, LIQUID INSIDE WAS FOUND TO BE LEAKED 1) DID THE VIAL CONTAIN PATIENT SAMPLE OR WAS THIS NOTICED PRIOR TO USE? YES, THE LAB OPERATOR FOUND THE LEAKAGE WHEN RECEIVING RETURNED VIALS FROM CLINIC. 2) IF IT CONTAINED PATIENT SAMPLE DID THE SAMPLE NEED TO BE RECOLLECTED? NO NEED, BECAUSE THE VIALS WERE PACKED INTO INDIVIDUAL SPECIMEN BAG AND THE LEAKAGE WERE TINY, NO RISK OF CONTAMINATION JUDGED BY THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590485 VIAL SUREPATH COLLECTION KIT 500 NA MKQ TRIPATH IMAGING, INC 491452 2160256 10382904914520

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown