BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARVEST TERUMO

    MDR report key: 8166329 · Received December 14, 2018

    Report

    Report Number
    1722028-2018-00341
    Event Type
    Malfunction
    Date Received
    December 14, 2018
    Date of Event
    October 31, 2018
    Report Date
    December 14, 2018
    Manufacturer
    TERUMO BCT
    Product Code
    FMF
    UDI-DI
    05020583514485
    PMA / PMN Number
    K043261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) LOT NUMBER, EXPIRY DATE AND MANUFACTURE DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: THE TECHNICIAN AT THE CUSTOMER SITE PROVIDED PHOTOGRAPHS OF BOTH THE INNER AND OUTER PACKAGING TO TERUMO BCT. THE LOT NUMBER ON THE BAN-25-0016 OUTER BOX HAD AN EXPIRATION DATE OF 01-AUG-2018. THE INNER, PRIMARY PACKAGING OF THE NEEDLE HAD A DIFFERENT EXPIRATION DATE OF 01-NOV-2018. THE PROCEDURE WAS PERFORMED ON (B)(6) 2018. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: PER FOLLOW UP, IT WAS FOUND THAT LOT BAN25-0016 WAS MANUFACTURED WITH TWO DIFFERENT VENDOR LOTS, HAVING EXPIRY OF 01-AUG-2018 ON ONE LOT AND EXPIRY OF 01-NOV-2018 ON ANOTHER LOT. AND SINCE THE KITS ARE LIMITED BY THE SHORTEST SHELF LIFE, THE OVERALL EXPIRATION DATE FOR BAN25-0016 IS 01-AUG-2018. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT, THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. THE HARVEST DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. HARVEST PRODUCT KITS CONTAIN MULTIPLE COMPONENTS THAT HAVE VARIOUS EXPIRATION DATES. THE OUTER KIT LABEL CONTAINS THE EXPIRATION DATE ASSOCIATED WITH THE COMPONENT THAT HAS THE SHORTEST EXPIRY TIMEFRAME. CORRECTION: TERUMO BCT CUSTOMER SUPPORT CONTACTED THE CUSTOMER TO DISCUSS THE IMPORTANCE OF CHECKING THE EXPIRATION DATE ON THE SET PRIOR TO THE PROCEDURE AND TO RETRAIN TO AVOID FURTHER USE OF EXPIRED KITS. THE CUSTOMER DECLINED THE REQUIREMENT FOR ADDITIONAL TRAINING. ROOT CAUSE: BASED ON THE CLINICAL FINDINGS, THE USE OF THE EXPIRED SET WAS CAUSED BY AN OPERATOR ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EXPIRED BONE MARROW ASPIRATE CONCENTRATE (BMAC) DISPOSABLE WAS USED ON A PATIENT. THE BMAC DISPOSABLE WAS LABELED WITH AN EXPIRATION DATE OF (B)(6) 2018. THE PROCEDURE WAS PERFORMED ON (B)(6) 2018. NO ADVERSE EVENTS REPORTED FOR THIS EVENT. THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION. THE BAN-25 8GA BM ASPIRATE NEEDLE IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003008 HARVEST TERUMO BAN-25 8GA BM ASPIRATE NEEDLE FMF TERUMO BCT 05020583514485

    Patients

    Seq Age Sex Outcome Treatment
    1 Other