BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 11208651 · Received January 21, 2021

    Report

    Report Number
    1024879-2021-00039
    Event Type
    Malfunction
    Date Received
    January 21, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678124
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. THEREFORE, TWENTY-NINE (29) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY BOTH VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE ISSUE RELATING TO DECAPPING WAS OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. EXTRA LUBRICANT ON THE STOPPERS COULD BE A CONTRIBUTOR FOR THE LOOSE CAP. HOWEVER, DUE TO UNKNOWN ENVIRONMENTAL CONDITIONS AFTER THE CUSTOMER TUBES LEAVING MANUFACTURING, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES STOPPER POPS OFF TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO. 367812 BATCH NO. 0100893 IT WAS REPORTED THAT THE TOPS ARE FALLING OFF THE TUBES. PER EMAIL: "WE SEEM TO BE HAVING AN ISSUE WITH THE TOPS STAYING ON. THEY¿RE FALLING OFF DURING TRANSPORT AND WHEN BEING SPUN DOWN. WE HAVEN¿T HAD THIS ISSUE BEFORE SO WE¿RE THINKING IT¿S A DEFECT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® SERUM BLOOD COLLECTION TUBES STOPPER POPS OFF TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367812 , BATCH NO. 0100893. IT WAS REPORTED THAT THE TOPS ARE FALLING OFF THE TUBES. PER EMAIL: WE SEEM TO BE HAVING AN ISSUE WITH THE TOPS STAYING ON. THEY¿RE FALLING OFF DURING TRANSPORT AND WHEN BEING SPUN DOWN. WE HAVEN¿T HAD THIS ISSUE BEFORE SO WE¿RE THINKING IT¿S A DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104542 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 0100893 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1