BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER EDTA 2K

    MDR report key: 11178084 · Received January 15, 2021

    Report

    Report Number
    1917413-2021-00022
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 17, 2020
    Report Date
    February 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-05. H6: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND 2 PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EMBEDDED FM ON THE TUBE AND SHIELD WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, ALL CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR EMBEDDED FM ON THE TUBE AND SHIELD WITH THE INCIDENT LOT WAS 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® EDTA 2K TUBE FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL WAS FOUND. THE EVENT OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER: THE FOLLOWING ISSUES WERE FOUND IN TUBES (367846) FROM LOT 0191214: DIRTY CAP ×1 AND SPOT IN TUBE ×1.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® EDTA 2K TUBE FOREIGN MATTER IN TUBE; BIOLOGICAL AND NON-BIOLOGICAL WAS FOUND. THE EVENT OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY INITIAL REPORTER: THE FOLLOWING ISSUES WERE FOUND IN TUBES (367846) FROM LOT 0191214: DIRTY CAP ×1. SPOT IN TUBE ×1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72570 BD VACUTAINER EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 0191214

    Patients

    Seq Age Sex Outcome Treatment
    1