BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SERUM BLOOD COLLECTION TUBES

    MDR report key: 11675922 · Received April 15, 2021

    Report

    Report Number
    1024879-2021-00255
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 23, 2021
    Report Date
    May 5, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678148
    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

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION OF MATERIAL # 367814, BATCH # 0316749. 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® SERUM BLOOD COLLECTION TUBE THERE WAS DIFFICULTY OR UNABLE TO PIERCE THROUGH THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER IS STAYING ON WHEN HEMOGARD IS REMOVED. CUSTOMER HAS AN AUTOMATED LAB SYSTEM, ROCHE 8100, WHICH REMOVES HEMOGARD STOPPERS FOR SAMPLING. IN THIS INSTANT, ONLY THE PLASTIC PORTION OF THE HEMOGARD PORTION WAS REMOVED, WHILE THE RUBBER STOPPER REMAINED IN PLACE, CAUSING AN ALARM TO GO OFF, WHICH SHUTS THE LINE DOWN COMPLETELY, AND NEGATIVELY AFFECTED TURNAROUND TIME FOR RESULTS FOR ALL TUBES ON THE LINE AT THE TIME."

    Additional Manufacturer Narrative · 1

    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® SERUM BLOOD COLLECTION TUBE THERE WAS DIFFICULTY OR UNABLE TO PIERCE THROUGH THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE STOPPER IS STAYING ON WHEN HEMOGARD IS REMOVED. CUSTOMER HAS AN AUTOMATED LAB SYSTEM, ROCHE 8100, WHICH REMOVES HEMOGARD STOPPERS FOR SAMPLING. IN THIS INSTANT, ONLY THE PLASTIC PORTION OF THE HEMOGARD PORTION WAS REMOVED, WHILE THE RUBBER STOPPER REMAINED IN PLACE, CAUSING AN ALARM TO GO OFF, WHICH SHUTS THE LINE DOWN COMPLETELY, AND NEGATIVELY AFFECTED TURNAROUND TIME FOR RESULTS FOR ALL TUBES ON THE LINE AT THE TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566460 BD VACUTAINER SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367814 0316749 50382903678148

    Patients

    Seq Age Sex Outcome Treatment
    1