BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® EDTA 2K

    MDR report key: 15412085 · Received September 13, 2022

    Report

    Report Number
    1917413-2022-00542
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 23, 2022
    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
    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 2022-09-08 H.6. INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE AND 3 PHOTOS FOR INVESTIGATION. THE SAMPLE AND PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DAMAGED CAP 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE DAMAGED CAP. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD VACUTAINER® EDTA 2K A CRACK ON THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT A CRACK ON THE CAP WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USING BD VACUTAINER® EDTA 2K A CRACK ON THE CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT A CRACK ON THE CAP WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579123 BD VACUTAINER® EDTA 2K BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 1259246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown