BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBE

    MDR report key: 12854182 · Received November 22, 2021

    Report

    Report Number
    9617032-2021-01197
    Event Type
    Malfunction
    Date Received
    November 22, 2021
    Date of Event
    October 29, 2021
    Report Date
    November 2, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1089514. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2021-03-30. MEDICAL DEVICE LOT #: 1232852. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-08-20. INVESTIGATION SUMMARY: BD DID RECEIVE 20 SAMPLES (BATCH: 1232852) FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 20 RETURNED SAMPLES (BATCH:1232852) AND 20 RETAINED SAMPLES (BATCH:1089514) WERE FUNCTIONALLY TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE OF OVERFILL WAS NOT OBSERVED AS ALL 40 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETURNED ( BATCH: 1232852) AND RETAINED (BATCH:1089514) SAMPLES TEST RESULTS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBE THERE WAS OVERFILL. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE BLOOD LEVEL IS ABOVE THE FILLING LINE ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1750493 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown