BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M

    MDR report key: 10528898 · Received September 14, 2020

    Report

    Report Number
    9617032-2020-00722
    Event Type
    Malfunction
    Date Received
    September 14, 2020
    Date of Event
    August 25, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903643054
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD RECEIVED 40 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. 20 RETURNED SAMPLES FROM EACH BATCH 0003983 AND 9329595. ALL SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBES ARE UNDER FILLING WITH BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M. THIS OCCURRED ON 5000 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CITRATE TUBES UNDER FILLING.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9329595, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2019-11-25, MEDICAL DEVICE LOT #: 0003983, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2020-01-03. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBES ARE UNDER FILLING WITH BD VACUTAINER® BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M. THIS OCCURRED ON 5000 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CITRATE TUBES UNDER FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997584 BD VACUTAINER BLOOD COLLECTION TUBES BUFFERED SODIUM CITRATE 0.3ML - 0.109M BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 364305 SEE H.10 50382903643054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other