BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11750126 · Received April 29, 2021

    Report

    Report Number
    1024879-2021-00286
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    April 6, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 15 RETENTION SAMPLES (FROM EACH LOT) FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO 'TUBE PUSH OFF' AS ALL SAMPLES MET SPECIFICATIONS. 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 WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED WHOLE TUBE PUSH OFF NON-PATIENT END OF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "PLEASE OPEN A CASE CONCERNING THE HOSPITAL LAB NOTED IN THE TABLE. THE MANAGER STATES THAT THE PHLEBOTOMIST HAS COMPLAINED THAT THE GOLD TOP TUBES ¿POP OUT¿ AND SHE HAS TO ¿HOLD IT ON¿ WHILE DRAWING BLOOD."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1020574. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2021-01-20. MEDICAL DEVICE LOT #: 1006118. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2021-01-06. 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 THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED WHOLE TUBE PUSH OFF NON-PATIENT END OF NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "PLEASE OPEN A CASE CONCERNING THE HOSPITAL LAB NOTED IN THE TABLE. THE MANAGER STATES THAT THE PHLEBOTOMIST HAS COMPLAINED THAT THE GOLD TOP TUBES ¿POP OUT¿ AND SHE HAS TO ¿HOLD IT ON¿ WHILE DRAWING BLOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642228 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 0342489 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1