BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 10548025 · Received September 17, 2020

    Report

    Report Number
    1917413-2020-00831
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 23, 2020
    Report Date
    October 16, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES. D.10. RETURNED TO MANUFACTURER ON: 9/28/2020. H.6. INVESTIGATION: BD RECEIVED 15 CITRATE TUBES OF LOT NUMBER 0100184 AND 15 CITRATE TUBES OF LOT NUMBER 0167174 AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 10 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 DURING USE WITH A BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WERE OVER FILLING. THIS OCCURRED WITH 2 TUBES FOR BOTH LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 8 COMPLAINTS). IT IS REPORTED CUSTOMER IS EXPERIENCING OVER 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 #: 0100184, MEDICAL DEVICE EXPIRATION DATE: 2020-10-31, DEVICE MANUFACTURE DATE: 2020-04-09, MEDICAL DEVICE LOT #: 0167174, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2020-006-15. ". 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 DURING USE WITH A BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WERE OVER FILLING. THIS OCCURRED WITH 2 TUBES FOR BOTH LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 8 COMPLAINTS). IT IS REPORTED CUSTOMER IS EXPERIENCING OVER FILLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016053 BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 363080 SEE H.10 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other