BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 16261264 · Received January 28, 2023

    Report

    Report Number
    9617032-2023-00103
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 26, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 #: 2145317. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2023. DEVICE MANUFACTURE DATE: 25-MAY-2022. MEDICAL DEVICE LOT #: 2153624. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2023. DEVICE MANUFACTURE DATE: 02-JUN-2022. INVESTIGATION SUMMARY: BD RECEIVED 200 SAMPLES (100 FOR BATCH: 2145317 AND 100 FOR BATCH: 2153624), AND 2 PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTOGRAPHS WERE EVALUATED AND SHOW LOW DRAW VOLUME LEVEL IN THE TUBES. ADDITIONALLY, 20 RETURNED SAMPLES FROM EACH BATCH NUMBERS: 2145317 AND 2153624 WERE FUNCTIONALLY TESTED AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED AS ALL 40 TUBES DREW WITHIN SPECIFICATION. THE COMPLAINT HAS BEEN CONFIRMED DUE TO THE PHOTOGRAPHS PROVIDED. ALTHOUGH PHOTOGRAPHS PROVIDED BY THE CUSTOMER DO INDICATE A LACK OF DRAW, THERE IS NO EVIDENCE THAT THE DEVICE WAS THE CAUSE OF THIS DEFECT. TESTING OF RETURNED SAMPLES FROM LOT NUMBERS PROVIDED: 2153624 AND 2145317 DID NOT CONFIRM THE REPORTED DEFECT. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 LOTS OF BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES THERE WAS A LOW DRAW OF BLOOD. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VACUUM PROBLEM. WHILE THE USER WAS TRYING TO TAKE A SAMPLE FROM THE PATIENT, THEY STATED THAT THE TUBES DID NOT VACUUM ENOUGH AND THAT THEY WERE ABLE TO DRAW BLOOD AT THE END DESPITE TRYING MORE THAN 10 TUBES FOR A PATIENT AND THEY STATED THAT THIS PROCESS CONTINUED IN A FEW PATIENTS AND THEY HAD A SIMILAR PROBLEM IN THE SECOND LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734045 BD VACUTAINER® K3E 5.4MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown