BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER TRACE ELEMENT SERUM BLOOD COLLECTION TUBES

    MDR report key: 11449495 · Received March 9, 2021

    Report

    Report Number
    1917413-2021-00170
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 17, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903683814
    PMA / PMN Number
    K041071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 0072556, D4: MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-18, H4: DEVICE MANUFACTURE DATE: 2020-03-12. H6: INVESTIGATION SUMMARY: BD RECEIVED 28 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND 10 OF THE 28 UNDERWENT DRAW TESTING AND THE INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO LEAKAGE 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES EXPERIENCED BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING BLOOD SPRAYING OUT OF THE TUBE AFTER USING THE NEEDLE ECLIPSE, TUBE IS REF#(B)(4). LOT NO. 0072556. NO EXPOSURE TO THE BLOOD BUT IT SPRAYED ON GLOVES, AND FLOOR. OCCURRED 3X.".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® TRACE ELEMENT SERUM BLOOD COLLECTION TUBES EXPERIENCED BLOOD SPLATTER/LEAKAGE OR OTHER SAMPLE LEAKAGE FROM DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "CUSTOMER IS REPORTING BLOOD SPRAYING OUT OF THE TUBE AFTER USING THE NEEDLE ECLIPSE, TUBE IS REF#368381, LOT NO. 0072556. NO EXPOSURE TO THE BLOOD BUT IT SPRAYED ON GLOVES, AND FLOOR. OCCURRED 3X."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345880 BD VACUTAINER TRACE ELEMENT SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 368381 0072556 50382903683814

    Patients

    Seq Age Sex Outcome Treatment
    1