BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 11120066 · Received January 5, 2021

    Report

    Report Number
    9617032-2020-01100
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 11, 2020
    Report Date
    April 13, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. 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. FURTHER TESTING IS NOT REQUIRED AT THIS TIME. CUSTOMER STATED THAT THE PREANALYTICAL ERROR WAS DUE TO INADEQUATE MIXING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES ERRONEOUS TCA RESULTS OCCURRED. PATIENT IMPACT WAS NOT REPORTED. SHORT DESCRIPTION: SHORTENED TCA RESULT ISSUES. WHERE DID THE OCCUR INCIDENT: AFTER USE. DETAILED INCIDENT DESCRIPTION: SINCE THE INTRODUCTION OF BATCH 0240225, ABNORMALLY. SHORTENED RESULTS HAVE BEEN OBSERVED FOR PATIENTS: BETWEEN 0.5 AND 0.7.

    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. FDA DEVICE PROBLEM CODE(S): (B)(4). FDA PATIENT PROBLEM CODE(S): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES ERRONEOUS TCA RESULTS OCCURRED. PATIENT IMPACT WAS NOT REPORTED. SHORT DESCRIPTION: SHORTENED TCA RESULT ISSUES WHERE DID THE OCCUR INCIDENT: AFTER USE DETAILED INCIDENT DESCRIPTION: SINCE THE INTRODUCTION OF BATCH 0240225, ABNORMALLY SHORTENED RESULTS HAVE BEEN OBSERVED FOR PATIENTS: BETWEEN 0.5 AND 0.7

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17221 BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0240225

    Patients

    Seq Age Sex Outcome Treatment
    1