BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS BLOOD COLLECTION TUBE

    MDR report key: 13765544 · Received March 15, 2022

    Report

    Report Number
    9617032-2022-00208
    Event Type
    Malfunction
    Date Received
    March 15, 2022
    Date of Event
    February 22, 2022
    Report Date
    March 18, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 23-MAR-2022. H6: INVESTIGATION SUMMARY: BD DID RECEIVE 110 SAMPLES (100 SAMPLES FOR THE BATCH: 1151084, 5 SAMPLES FOR THE BATCH: 1228728 AND 5 SAMPLES FOR THE BATCH: 1181919) FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. 5 RETURNED AND 20 RETAINED SAMPLES FROM THE BD INVENTORY OF EACH BATCH NUMBER: 1228728 AND 1181919 WERE FUNCTIONALLY TESTED WITH AND THE CUSTOMER'S INDICATED FAILURE MODE OF UNDERFILL WAS NOT OBSERVED AS ALL THE TUBES DREW WITHIN SPECIFICATION. ADDITIONALLY, THE EXPIRATION DATE OF THE LOT NUMBER INVOLVED: 1151084 (100 RETURNED TUBES) WAS FEBRUARY 2022. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETURNED AND RETAINED SAMPLES TEST RESULTS FOR THE BATCHES: 1181919, 1228728. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FOR THE BATCH: 1151084 BECAUSE THE TUBES HAS EXPIRED. NO 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: . MEDICAL DEVICE LOT #: 1228728 MEDICAL DEVICE EXPIRATION DATE: 2022-04-30 . DEVICE MANUFACTURE DATE: 2021-08-16. MEDICAL DEVICE LOT #: 1151084. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28 . DEVICE MANUFACTURE DATE: 2021-05-31. MEDICAL DEVICE LOT #: 1181919. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2021-06-30. 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 · 0

    IT WAS REPORTED THAT 1 BD VACUTAINER® PLUS BLOOD COLLECTION TUBE EACH FROM LOTS 1228728, 1151084, AND 1181919 UNDERFILLED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FROM AN AUDIT CARRIED OUT... THERE WERE MULTIPLE LOT NUMBERS AFFECTED I.E. SAMPLES THAT WERE REPORTED AS UNDERFILLED... LOT: 1228728, EXP.: 30/04/22. LOT: 1151084, EXP.: 28/02/22. LOT: 1181919, EXP.: 31/03/22. FROM PRIOR DISCUSSIONS WITH OUR PHLEBOTOMY LEAD... SHE HAS CONFIRMED THEIR PRACTICE IS TO USE A DISCARD TUBE WHEN NECESSARY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VACUTAINER® PLUS BLOOD COLLECTION TUBE EACH FROM LOTS 1228728, 1151084, AND 1181919 UNDERFILLED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FROM AN AUDIT CARRIED OUT... THERE WERE MULTIPLE LOT NUMBERS AFFECTED I.E. SAMPLES THAT WERE REPORTED AS UNDERFILLED... LOT: 1228728 EXP.: 30/04/22 LOT: 1151084 EXP.: 28/02/22 LOT: 1181919 EXP.: 31/03/22 FROM PRIOR DISCUSSIONS WITH OUR PHLEBOTOMY LEAD... SHE HAS CONFIRMED THEIR PRACTICE IS TO USE A DISCARD TUBE WHEN NECESSARY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664830 BD VACUTAINER® PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363095 SEE SECTION H10 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown