BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 21698667 · Received March 26, 2025

    Report

    Report Number
    9617032-2025-00474
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 27, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903659006
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E1. INITIAL REPORTER FACILITY NAME: (B)(6) MEDICAL UNIVERSITY. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4073118. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025. H4. DEVICE MANUFACTURE DATE: 13-MAR-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 25-MAR-2025. INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS AND TWO SAMPLES FOR INVESTIGATION, INCLUDING ONE SAMPLE FROM LOT 4073118 AND ONE SAMPLE FROM LOT 4145587. EVALUATION OF THE PHOTOS INDICATED A YELLOWISH EDTA CLUMP IN THE TUBE. THE INVESTIGATION OF THE RETURNED SAMPLES REVEALED EDTA CLUMPS IN THE TUBE FROM LOT NUMBER 4073118, WHILE NO EDTA CLUMPS WERE OBSERVED IN THE TUBE FROM LOT NUMBER 4145587. DUE TO THE SIZE OF THE DEPOSIT THE ADDITIVE HAS YELLOWED SLIGHTLY ON IRRADIATION. THIS IS RECOGNIZED TO BE AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICIENCY OF THE TUBE. ADDITIONALLY, (B)(4) RETAINED SAMPLES FROM EACH LOT NUMBER ((B)(4) SAMPLES IN TOTAL) WERE VISUALLY INSPECTED, AND EDTA CLUMPS WERE FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR ADDITIVE ABNORMALITY. 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 THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES, ADDITIVE ABNORMALITIES WERE OBSERVED IN 2 TUBES(ONE IN EACH REPORTED LOT #). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES, ADDITIVE ABNORMALITIES WERE OBSERVED IN 2 TUBES (ONE IN EACH REPORTED LOT #). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694837 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 4145587 30382903659006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown