BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES

    MDR report key: 7692936 · Received July 17, 2018

    Report

    Report Number
    1917413-2018-02995
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    June 21, 2018
    Report Date
    August 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. BD HAS CONDUCTED FOLLOW UP WITH THE CUSTOMER AND SHARED A TUBE VOLUME GUIDE. THE CUSTOMER HAS INDICATED THAT THE ISSUE HAS BEEN RESOLVED. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA. THE CAPA HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES WERE OVERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7305990, MEDICAL DEVICE EXPIRATION DATE: 08/31/2018, RETURNED TO MANUFACTURER ON: N/A, DEVICE MANUFACTURE DATE: 11/01/2017. MEDICAL DEVICE LOT #: 8061553, MEDICAL DEVICE EXPIRATION DATE: 12/31/2018, RETURNED TO MANUFACTURER ON: N/A, DEVICE MANUFACTURE DATE: 03/02/2018 ". 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 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES WERE OVERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538341 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 8074678 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other