BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE ACD GH 13X100 6.0 PLBLCE YEL

    MDR report key: 10426372 · Received August 19, 2020

    Report

    Report Number
    9617032-2020-00663
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    August 12, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: CUSTOMER STATES THAT THE PRODUCT THEY HAVE ORDERED WAS PCN 367756 LOT 0023671 AND IN BETWEEN 1000 UNITS RECEIVED THERE WERE 2 SHELF PACKS PCN 367950, LOT 0056963. PHOTOGRAPHS WERE ATTACHED SHOWING 2 UNUSED TUBES. THE PRODUCT 367756, LOT 0023671 WAS MANUFACTURED ON 05/02/2020 AND HAD ALREADY BEEN SHIPPED FROM THE MANUFACTURING SITE BEFORE THE PRODUCT PCN 367950 LOT 0056963 BEGAN TO BE MANUFACTURED. PCN 367950, LOT 0056963 WAS MANUFACTURED ON 08/03/2020. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MIX OF PRODUCT WITH 200 BD TUBE ACD GH 13 X 100 6.0 PLBLCE YEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ORDERED AND RECEIVED 1000 VACUTAINER EDTA K2 TUBE 6ML YELLOW ON 14.07/2020, WITHIN THE BOX THERE WERE 2 PACKS OF 100 OF ITEM CODE 367756 LEMON TOP ACD SOLUTION, APPROX 30 HAVE BEEN ISSUED OUT AND WE ARE TRYING TO RECALL THE ITEM FROM WARDS .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889452 BD TUBE ACD GH 13X100 6.0 PLBLCE YEL BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0023671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other