BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES

    MDR report key: 16323864 · Received February 8, 2023

    Report

    Report Number
    9617032-2023-00139
    Event Type
    Malfunction
    Date Received
    February 8, 2023
    Date of Event
    January 25, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630481
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 1 PHOTOGRAPH AND 100 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. EVALUATION OF THE PHOTOGRAPH ATTACHED SHOWS LOW DRAW VOLUME IN THE TUBES. 20 RETURNED SAMPLES WERE DRAW-TESTED WITH DEIONIZED WATER. FROM THIS TESTING, IT WAS DETERMINED THAT ALL 20 TUBES DREW WITHIN SPECIFICATION. THE COMPLAINT HAS BEEN CONFIRMED DUE TO THE PHOTOGRAPH PROVIDED. ALTHOUGH PHOTOGRAPH PROVIDED BY THE CUSTOMER DO INDICATE A LACK OF DRAW, THERE IS NO EVIDENCE THAT THE DEVICE WAS THE CAUSE OF THIS DEFECT. TESTING OF RETURNED SAMPLES FROM LOT NUMBER PROVIDED: 2256241 DID NOT CONFIRM THE REPORTED DEFECT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 2253241 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 3 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES THE TUBES UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PROBLEM OF FILLING TUBES IN THE RESUSCITATION AND CARDIO DEPARTMENT AND OTHER 9% OF REJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 3 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES THE TUBES UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PROBLEM OF FILLING TUBES IN THE RESUSCITATION AND CARDIO DEPARTMENT AND OTHER 9% OF REJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2314095 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363048 2253241 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown