BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 7601274 · Received June 14, 2018

    Report

    Report Number
    9617032-2018-01620
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    September 13, 2016
    Report Date
    May 25, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6120822, MEDICAL DEVICE EXPIRATION DATE: 10/31/2017, DEVICE MANUFACTURE DATE: 04/29/2016, MEDICAL DEVICE LOT #: 6089884, MEDICAL DEVICE EXPIRATION DATE: 09/30/2017, DEVICE MANUFACTURE DATE: 03/29/2016. (B)(6). BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BASED ON EVALUATION OF THE COMPLAINT INFORMATION, THIS COMPLAINT MEETS THE CRITERIA FOR A PREVIOUSLY INVESTIGATED COMPLAINT, REFERENCE (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES WERE UNDERFILLING. NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442206 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5264222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other