BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR

    MDR report key: 17276069 · Received July 6, 2023

    Report

    Report Number
    3003916417-2023-00145
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Date of Event
    June 15, 2023
    Report Date
    November 2, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.6. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 360057 LOT/BATCH #: 2181429 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, FIVE (5) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR DID NOT FILL PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER MENTIONS THAT 4 ML EDTA TUBES DO NOT FILL TO AN ADEQUATE LEVEL, HAVING AN APPROXIMATE DEFICIT OF 20 TO 25%. THE TUBES ARE OCCUPIED BY CESFAM, WHICH SENDS SAMPLES TO THE HOSPITAL'S LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR DID NOT FILL PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER MENTIONS THAT 4 ML EDTA TUBES DO NOT FILL TO AN ADEQUATE LEVEL, HAVING AN APPROXIMATE DEFICIT OF 20 TO 25%. THE TUBES ARE OCCUPIED BY CESFAM, WHICH SENDS SAMPLES TO THE HOSPITAL'S LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422147 BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2181429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown