BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 19089771 · Received April 11, 2024

    Report

    Report Number
    9617032-2024-00563
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 22, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903688432
    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

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN E.4.INITIAL REPORTER FACILITY NAME: (B)(6) CENTER H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D4. MEDICAL DEVICE LOT #: 3241845. D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2024. D10. DEVICE AVAILABLE FOR EVAL- YES . D10. RETURNED TO MANUFACTURER ON: 20-MAY-2024. H4. DEVICE MANUFACTURE DATE: 29-AUG-2023. H.6. INVESTIGATION SUMMARY: BD RECEIVED A SAMPLE AND THREE (3) PHOTOS FOR INVESTIGATION. THE SAMPLE AND PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR MISSING STOPPER WAS OBSERVED. ADDITIONALLY, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF MISSING STOPPER WAS NOT OBSERVED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF IMPROPER ASSEMBLY. BD WAS NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES THE TUBE STOPPER WAS MISSING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING THE BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES THE TUBE STOPPER WAS MISSING. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690402 BD VACUTAINER® K2E 3.6MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3241845 00382903688432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown