BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TRUCOUNT TUBES

    MDR report key: 12160563 · Received July 13, 2021

    Report

    Report Number
    2916837-2021-00306
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 17, 2021
    Report Date
    August 5, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    UDI-DI
    00382903403349
    PMA / PMN Number
    K970836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT # 2916837-2021-00306 WAS SENT IN ERROR. A PHOTO PROVIDED BY THE CUSTOMER ILLUSTRATE A BOX WITH THE BATCH 1112420 THAT CORRESPOND TO THE BATCH NUMBER FOR THE KIT OF MATERIAL 340344 AND THE POUCH WITH THE REFERENCE BATCH 21087 THAT CORRESPONDS TO THE BATCH NUMBER FOR THE SEMIFINISHED MATERIAL. THE ILLUSTRATION REPRESENTS HOW BD MANUFACTURE AND PACK FINISHED MATERIALS. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOT # ON 12 BAGS IS DIFFERENT THAN THE LOT # ON THE SHIPPER WITH A BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE BATCH OF THE PRODUCT PACKAGING BOX DOES NOT MATCH THE BATCH OF THE INNER BAG.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: PMA / 510(K)#: K090967, K980858, K971205, K971110, K970326, K970742, AND K071143. 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 · 1

    IT WAS REPORTED THAT THE LOT # ON 12 BAGS IS DIFFERENT THAN THE LOT # ON THE SHIPPER WITH A BD TRUCOUNT¿ TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE BATCH OF THE PRODUCT PACKAGING BOX DOES NOT MATCH THE BATCH OF THE INNER BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053886 BD TRUCOUNT TUBES COUNTER, DIFFERENTIAL CELL GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 340334 1112420 00382903403349

    Patients

    Seq Age Sex Outcome Treatment
    1