BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 19066890 · Received April 8, 2024

    Report

    Report Number
    1917413-2024-00293
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 11, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678469
    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

    H.6. INVESTIGATION SUMMARY: BD RECEIVED A USED CUSTOMER SAMPLE, AND 7 PHOTOS WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367846, LOT NUMBER 3223314. VISUAL EXAMINATION OF THE SAMPLES AND THE PHOTOS WAS PERFORMED AND REVEALED EMBEDDED FM IN THE SIDEWALL OF THE TUBE. THERE IS A WHITE SPOT IN THE SIDEWALL OF THE TUBE. BD RINSED THE TUBE WITH WATER AND THE WHITE SPOT REMAINED ON THE TUBE WALL, THE SPOT WAS ALSO RUBBED WITH A COTTON SWAB AND WAS NOT ABLE TO BE REMOVED. EMBEDDED FM IS, BY ITS NATURE, ISOLATED FROM ANY SPECIMEN, THEREFORE IT IS A COSMETIC DEFECT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE EXACT CAUSE FOR THE CUSTOMER'S FAILURE MODE COULD NOT BE DETERMINED. 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. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K THERE WAS A WHITE STAIN-LIKE SUBSTANCE IN THE TUBE (FOREIGN MATTER). THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® EDTA 2K THERE WAS A WHITE STAIN-LIKE SUBSTANCE IN THE TUBE (FOREIGN MATTER). THERE WAS NO REPORT OF IMPACT ON THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109342 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3223314 50382903678469

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown