BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9482994 · Received December 17, 2019

    Report

    Report Number
    1917413-2019-02531
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOS FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. BD IS CONTINUALLY MONITORING COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION IN ORDER TO IDENTIFY EMERGING TRENDS. H3 OTHER TEXT: SEE H.10.

    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. 9260289 AND UNKNOWN THE HEMATOLOGY DEPARTMENT HAS NOTICED THAT THEY HAVE BEEN RECEIVING OVERFILLED TUBES. IT WAS PRESUMED THAT NURSING STAFF WERE POSSIBLY USING SYRINGES TO FILL TUBES AND INADVERTENTLY OVERFILLING THEM, SO I SENT AN EMAIL OUT THE NURSING EDUCATION TRYING TO GET AHEAD OF A BIG ISSUE. I HAVE SINCE HEARD BACK FROM A FEW NURSE MANAGERS STATING THAT THE TUBES ARE OVERFILLING ON THEIR OWN AND THEY ARE NOT ABLE TO PULL THE TUBE BEFORE IT OVERFILLS. IT SEEMS TO BE A VACUUM ISSUE AS NONE OF ARE USING SYRINGES WHEN FILLING THESE TUBES. I DID GET A LOT NUMBER FROM ER OF 9260289, BUT I CAN¿T SAY FOR CERTAIN WHETHER THAT IS THE LOT NUMBER INVOLVED IN ALL OF THE OVERFILLED INSTANCES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER OCCUPATION: SPECIMEN ACQUISITION AND DISTRIBUTION SUPERVISOR. 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 #: 9260289. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. DEVICE MANUFACTURE DATE: 2019-09-17. MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    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#: 363083, BATCH#: 9260289, AND UNKNOWN. THE HEMATOLOGY DEPARTMENT HAS NOTICED THAT THEY HAVE BEEN RECEIVING OVERFILLED TUBES. IT WAS PRESUMED THAT NURSING STAFF WERE POSSIBLY USING SYRINGES TO FILL TUBES AND INADVERTENTLY OVERFILLING THEM, SO I SENT AN EMAIL OUT THE NURSING EDUCATION TRYING TO GET AHEAD OF A BIG ISSUE. I HAVE SINCE HEARD BACK FROM A FEW NURSE MANAGERS STATING THAT THE TUBES ARE OVERFILLING ON THEIR OWN AND THEY ARE NOT ABLE TO PULL THE TUBE BEFORE IT OVERFILLS. IT SEEMS TO BE A VACUUM ISSUE AS NONE OF ARE USING SYRINGES WHEN FILLING THESE TUBES. I DID GET A LOT NUMBER FROM ER OF 9260289, BUT I CAN¿T SAY FOR CERTAIN WHETHER THAT IS THE LOT NUMBER INVOLVED IN ALL OF THE OVERFILLED INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279984 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