BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 13698421 · Received March 8, 2022

    Report

    Report Number
    2243072-2022-00320
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 25, 2022
    Report Date
    March 15, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627603
    PMA / PMN Number
    K911731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES HAVE LOW FILL VOLUME. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (BROKEN BOW) MEDICAL DEVICE CATALOG #: 362760. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (BROKEN BOW). PMA / 510(K)#: K911731. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ". IT WAS REPORTED THAT TUBES HAVE LOW FILL VOLUME. ".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD VACUTAINER UNDERFILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT TUBES HAVE LOW FILL VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429627 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362760 UNKNOWN 50382903627603

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown