BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 21034768 · Received December 30, 2024

    Report

    Report Number
    1917413-2024-01327
    Event Type
    Malfunction
    Date Received
    December 30, 2024
    Date of Event
    December 11, 2024
    Report Date
    February 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678465
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: 10-JAN-2025. INVESTIGATION SUMMARY: BD RECEIVED TWO SAMPLES AND EIGHT PHOTOS FOR INVESTIGATION. A VISUAL EXAMINATION OF THE SAMPLES AND PHOTO EVALUATION REVEALED EMBEDDED FOREIGN MATERIAL (FM) IN THE SIDEWALL OF THE TUBE AND WHITE SPECKS IN THE TUBE SIDEWALL. EMBEDDED FM IS CONSIDERED A COSMETIC DEFECT, AS IT IS ISOLATED FROM ANY SPECIMEN. PREVIOUS INVESTIGATIONS SUGGEST THAT EMBEDDED FM MAY RESULT FROM RESIN COLORANT OR RESIN ADHERING TO THE INTERIOR OF THE MOLD CORE AND BREAKING FREE DURING PRODUCTION, TYPICALLY SEEN AT THE START OF A RUN OR IF THE MOLD HAD TO BE STOPPED FOR MAINTENANCE AND THEN RESTARTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: EMBEDDED FOREIGN MATTER. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN E1. INITIAL REPORTER FACILITY NAME: (B)(6) H4. DEVICE MANUFACTURE DATE: UNKNOWN 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 AFTER USING BD VACUTAINER® EDTA 2K, A WHITE FOREIGN BODY WAS FOUND IN THE BLOOD SAMPLE. THIS OCCURRED THREE (3) TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED AFTER USING BD VACUTAINER® EDTA 2K, A WHITE FOREIGN BODY WAS FOUND IN THE BLOOD SAMPLE. THIS OCCURRED THREE (3) TIMES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732741 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 30382903678465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown