BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9483032 · Received December 17, 2019

    Report

    Report Number
    1917413-2019-02532
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    December 2, 2019
    Report Date
    February 10, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630832
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED OVER FILL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 363083, BATCH NO. 9220391, 9260285 AND 9260286 . INFORMATION RECEIVED -THEY HAVE HAD TWO LOTS THAT HAVE BEEN OVERFILLING. DATE OF EVENT: WEEK OF (B)(6) (LOT 9220391). DATE OF EVENT: UNKNOWN (LOT 9260285). DATE OF EVENT: (B)(6) 2019 (LOT 9260286). PATIENT IDENTIFIERS: NONE AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9220391, MEDICAL DEVICE EXPIRATION DATE: 2020-05-31, DEVICE MANUFACTURE DATE: 2019-08-08, MEDICAL DEVICE LOT #: 9260285, MEDICAL DEVICE EXPIRATION DATE: 2020-06-30, DEVICE MANUFACTURE DATE: 2019-09-17, MEDICAL DEVICE LOT #: 9260286, MEDICAL DEVICE EXPIRATION DATE: 2020-06-30, DEVICE MANUFACTURE DATE: 2019-09-17.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES EXPERIENCED OVER FILL DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 363083, BATCH NO. 9220391, 9260285 AND 9260286. INFORMATION RECEIVED: THEY HAVE HAD TWO LOTS THAT HAVE BEEN OVERFILLING. DATE OF EVENT: WEEK OF NOV 25TH (LOT 9220391), DATE OF EVENT: UNKNOWN (LOT 9260285), DATE OF EVENT: (B)(6) 2019 (LOT 9260286), PATIENT IDENTIFIERS: NONE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280006 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363083 SEE H.10 50382903630832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other