BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE-TEK® BIOPSY BAGS, SMALL; 1,000 BAGS/BOX

    MDR report key: 19169504 · Received April 23, 2024

    Report

    Report Number
    2083544-2024-00005
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    September 12, 2023
    Report Date
    April 12, 2024
    Manufacturer
    SAKURA FINETEK USA, INC.
    Product Code
    NNK
    UDI-DI
    00615233078391
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON BEING NOTIFIED BY THE FDA ON 03-APR-2024, SAKURA FINETEK USA TRIED REACHING OUT TO THE CUSTOMER (B)(6) CLINIC) AND THE INITIATER (B)(6)) OF THE FDA REPORT MULTIPLE TIMES ON B)(6) OF THE YEAR 2024 FOR FURTHER INFORMATION ON THE INCIDENT AS SAKURA FINETEK USA WAS NOT NOTIFIED OF THE EVENT BY THE CUSTOMER IN 2023. B)(6) OF B)(6) CLINIC (CUSTOMER) RESPONDED ON B)(6) THAT THEY DID NOT HAVE ANY FURTHER INFORMATION AS THERE WERE NO AFFECTED LOTS IN THEIR INVENTORY AT THE MOMENT AND HENCE THEY WOULD NOT BE ABLE TO VERIFY AFFECTED LOTS AT THIS POINT IN TIME. THE REPORT FILED TO THE FDA IN 2023 BY THE CUSTOMER DOES NOT CONTAIN DEVICE LOT NUMBER AS WELL. IN 2023, SAKURA FINETEK USA HAD OBSERVED OF THIS ISSUE INTERNALLY ON SOME SPECIFIC LOT NUMBERS OF THE DEVICE IN QUESTION AND HAD PROACTIVELY REACHED TO THE CUSTOMERS WHO HAD RECEIVED THE AFFECTED LOTS VIA ADVISORY NOTICE ALSO REQUESTING THE CUSTOMERS TO CONTACT SAKURA FINTEK USA TECH SUPPORT FOR REPLACEMENT LOT. B)(6) OF B)(6) CLINIC (CUSTOMER) CONFIRMED THAT THEIR RECORDS INDICATE THAT THEY HAVE RECEIVED NOTIFICATION OF THIS DEVICE PROBLEM AND ADVISORY NOTICE FROM SAKURA FINTEK USA ON B)(6) 2023 AND A SECOND NOTIFICATION FROM THEIR DISTRIBUTORS ON B)(6) 2024. BASED ON THE INVESTIGATION IN 2023, SAKURA FINTEK FOUND THAT THE PROBLEM WAS A SEALING ISSUE DUE TO DEVICE MANUFACTURING UNIT MALFUNCTIONING AT THE SUPPLIER END AND THE SUPPLIER WAS UNABLE TO IDENTIFY THE ISSUE DURING QUALITY CHECKS BEFORE SHIPPING IT TO SAKURA FINETEK. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO SUPPLIER AND ADDITIONAL QUALITY TESTING FOR SEAL QUALITY WAS INCORPORATED IN THE MANUFACTURING PROCESS BY THE SUPPLIER AS WELL AS DURING INCOMING PRODUCT INSPECTION AT SAKURA FINETEK USA FACILITY. THIS INCIDENT IS FOR DEVICE MALFUNCTION AND NO IMPACT TO THE PATIENT TISSUE WAS REPORTED.

    Description of Event or Problem · 0

    SAKURA FINETEK USA WAS NOTIFIED BY FDA ON 3-APR-2024 ABOUT THE MEDICAL DEVICE REPORT SUBMITTED VIA MEDWATCH PROGRAM. THE EMAIL NOTIFICATION FROM FDA INCLUDED NOTIFICATION LETTER AND THE SUBMITTED MEDICAL DEVICE REPORT FOR SAKURA FINETEK USA'S AWARENESS. THE MEDICAL DEVICE REPORT (FORM 3500A) WAS SUBMITTED BY THE CUSTOMER'S REPRESENTATIVE, (B)(6) OF (B)(6) CLINIC LOCATED IN (B)(6) IN B)(6) 2023 FOR THE EVENT THAT TOOK PLACE IN B)(6) 2023. IN THE REPORT SUBMITTED TO THE FDA, CUSTOMER HAS DESCRIBED THAT THE MESH BIOPSY BAGS ARE USED TO HOLD TISSUES WHEN GROSSING TO KEEP THEM SAFE, BEFORE BEING INSERTED INTO CASSETTES. THE MESH BAGS THAT WERE THEN THEIR CURRENT LOT WERE TEARING APART AT THE EDGES WHEN OPENING THEM TO PUT TISSUES IN AND NOT HOLDING THEIR SHAPE. THE CUSTOMER MENTIONED THAT THIS DEVICE DEFECT GIVES TISSUES THE POTENTIAL TO BE LOST OUT THE SIDE OF THESE BAGS. THEY ALSO HAVE MENTIONED THAT, THERE HAD BEEN AN INCREASE IN NUMBER OF BAGS TEARING APART AT THE EDGES CAUSING THE GROSSING TECH TO THROW THEM AWAY OR IF THEY ARE NOT CAUGHT AT THE TIME A POTENTIAL FOR LOSS OF IRRETRIEVABLE TISSUES. THEY HAVE CATEGORIZED THE USER PROBLEM AS DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381897 TISSUE-TEK® BIOPSY BAGS, SMALL; 1,000 BAGS/BOX BIOPSY BAGS NYLON,SMALL 1000/CS (30X50 MM) NNK SAKURA FINETEK USA, INC. 4223 00615233078391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown