BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 11791547 · Received May 7, 2021

    Report

    Report Number
    1024879-2021-00298
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 9, 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
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION OF MATERIAL # 367812, BATCH # 0080944. THEREFORE, 29 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY STOPPER PULLOUT TESTING AND LOOSE CAPS WERE OBSERVED WITH 4 OUT OF 29 SAMPLES FAILING THE STOPPER PULLOUT TESTING. 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. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION CAPA INVESTIGATION 1875009 RELATING TO THE ISSUE OF LOOSE CAPS THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES DEVICE EXPERIENCED STOPPER CREEP OUT OR LOOSE CLOSURE.THIS EVENT OCCURRED 1400 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "GOT THE INFORMATION SAYING THAT CAPS ARE VERY LOOSE .POP UP ISSUE."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES DEVICE EXPERIENCED STOPPER CREEP OUT OR LOOSE CLOSURE. THIS EVENT OCCURRED 1400 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "GOT THE INFORMATION SAYING THAT CAPS ARE VERY LOOSE .POP UP ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689608 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367812 0080944 50382903678124

    Patients

    Seq Age Sex Outcome Treatment
    1