BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 21610411 · Received March 14, 2025

    Report

    Report Number
    9617032-2025-00382
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    September 13, 2023
    Report Date
    March 19, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#:3027843. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024. H4. DEVICE MANUFACTURE DATE: 27-JAN-2023. D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). D4. MEDICAL DEVICE LOT#:3135993. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 15-05-2023. D4. UNIQUE IDENTIFIER (UDI) #:(B)(4).

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH A CORRECTION: D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). INVESTIGATION SUMMARY - BD RECEIVED THREE (3) PHOTOS FOR INVESTIGATION. THE EVALUATION OF THE PHOTOS INDICATES FOREIGN MATTER IN USED TUBES AND MOLDING DEFECTS ON THE CAPS. A TOTAL OF 300 RETAINED SAMPLES, 100 FROM EACH LOT NUMBER, WERE VISUALLY EXAMINED AND NO FOREIGN MATTER OR MOLDING DEFECTS WERE OBSERVED. 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 THE LOT 3027843, FOR THE INDICATED FAILURE MODES FOREIGN MATTER - UNKNOWN AND MOLDED PART HAS DEFECTS - SHARP PROTRUSIONS BASED ON CUSTOMER PHOTOS PROVIDED. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 3080530, FOR THE INDICATED FAILURE MODES FOREIGN MATTER - UNKNOWN AND MOLDED PART HAS DEFECTS - SHARP PROTRUSIONS BASED ON CUSTOMER PHOTOS PROVIDED. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE LOT 3135993, FOR THE INDICATED FAILURE MODES FOREIGN MATTER - UNKNOWN AND MOLDED PART HAS DEFECTS - SHARP PROTRUSIONS BASED ON CUSTOMER PHOTOS PROVIDED. 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 THAT WHILE USING BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES, THE CUSTOMER NOTICED FILAMENTS OUTSIDE AND IN BETWEEN THE CAP OF THE TUBE ON UNSPECIFIED NUMBER OF TUBES. NO PATIENT OR USER IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES, THE CUSTOMER NOTICED FILAMENTS OUTSIDE AND IN BETWEEN THE CAP OF THE TUBE ON UNSPECIFIED NUMBER OF TUBES. NO PATIENT OR USER IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690052 BD VACUTAINER® K2E (EDTA) 10.8MG PLUS BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON, DICKINSON AND COMPANY (BD) 3080530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown