BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI BONE MARROW BIOPSY TRAY

    MDR report key: 10687496 · Received October 15, 2020

    Report

    Report Number
    1625685-2020-00092
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 16, 2020
    Report Date
    February 23, 2021
    Manufacturer
    CAREFUSION, INC
    Product Code
    KNW
    PMA / PMN Number
    K171531
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED THAT THE CASE LABEL HAS AN INCORRECT EXPIRATION DATE FOR LOT #0001325788. EXPIRATION DATE ON THE CASE LABEL IS 2022-10-31 AND THE EXPIRATION DATE ON THE TRAY WEB IS 2020-10-31. THE AFFECTED PRODUCT WAS RETURNED FOR INVESTIGATION. SAMPLE EVALUATION CONFIRMED THE REPORTED FAILURE MODE. THE CASE LABEL HAS AN INCORRECT EXPIRATION DATE FOR LOT #0001325788. BASED ON THE COMPLAINT INVESTIGATION, POTENTIAL CONTRIBUTIONS WERE IDENTIFIED FROM BOTH MANUFACTURING PERSONNEL AND PROCESSES. THE MOST PROBABLE ROOT CAUSE IS THAT MANUFACTURING PERSONNEL AND PROCESSES FOR LABEL VERIFICATION DID NOT PROPERLY IDENTIFY THE INCORRECT EXPIRATION DATE THAT WAS PRINTED ON CASE LABEL. ALL APPLICABLE MANUFACTURING ASSOCIATES WILL RECEIVE AWARENESS TRAINING. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED AND TRENDED THROUGH THE QUALITY DATA ANALYSIS PROCESS FOR FUTURE OCCURRENCES. CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. H3 OTHER TEXT: SEE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXPIRATION ON THE OUTER BOX IS (B)(6) 2020, BUT ON THE PACKAGING IT IS (B)(6) 2022.

    Additional Manufacturer Narrative · 1

    PR (B)(4): INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXPIRATION ON THE OUTER BOX IS 2020-10-31, BUT ON THE PACKAGING IT IS 2022-10-31. DETAILED DESCRIPTION OF EVENT: THE EXPIRY DATE PRINTED ON THE PRODUCT IS 2020-10-31, BUT PRINTED ON OUTER PACKING IS 2022-10-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148906 JAMSHIDI BONE MARROW BIOPSY TRAY INSTRUMENT, BIOPSY KNW CAREFUSION, INC 0001325788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other