BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8642197 · Received May 24, 2019

    Report

    Report Number
    9617032-2019-00621
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    May 9, 2019
    Report Date
    June 12, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ADDITIONAL INFORMATION/CHANGES ARE AS FOLLOWS: MEDICAL DEVICE BRAND NAME: BLOOD SPECIMEN COLLECTION DEVICE. MEDICAL DEVICE TYPE: JKA . COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (BROKEN BOW). MEDICAL DEVICE CATALOG #: 363083. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (BROKEN BOW). PMA / 510(K)# K013971.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OVERFILL OCCURRED WITH A BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER TEXT: WE HAVE NOTICED ON SEVERAL OCCASIONS, THAT OUR 1.ML SODIUM CITRATE VACUTAINER TUBES (LOT#9043983) ARE OVERFILLING. LAST APRIL (2018) WE HAD RECEIVED NOTIFICATION OF THE SAME ISSUE OCCURRING WITH THE 2.ML SODIUM CITRATE." 1 OF 2 COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. PLEASE NOTE THAT THE FILL LINE PRESENT FOR THE TNT PRODUCT IS A MINIMUM FILL LINE. THERE ARE NO MAXIMUM FILL LINES PRESENT ON THE TNT TUBES. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVEFILL OCCURRED WITH A BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER TEXT: WE HAVE NOTICED ON SEVERAL OCCASIONS, THAT OUR 1.ML SODIUM CITRATE VACUTAINER TUBES (LOT#9043983) ARE OVERFILLING. LAST APRIL (2018) WE HAD RECEIVED NOTIFICATION OF THE SAME ISSUE OCCURRING WITH THE 2.ML SODIUM CITRATE." 1 OF 2 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432486 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other