BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 11197971 · Received January 19, 2021

    Report

    Report Number
    9617032-2021-00057
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    December 29, 2020
    Report Date
    February 24, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BD WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S ISSUE. 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. BD WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE CUSTOMER'S ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNDERFILL/LOW DRAW OCCURRED WHILE USING THE BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES. THIS OCCURRED ON 2,000 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOSPITAL REPORTED UNDERFILLING BD CITRATE TUBES (2,7 ML, REF (B)(4). BD KAM TESTED AND CONFIRMED THAT THE TUBES WERE UNDERFILLED WITH WATER AFTER STANDARD PROCEDURE OF TUBE CHECKING.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERFILL/LOW DRAW OCCURRED WHILE USING THE BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES. THIS OCCURRED ON 2,000 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HOSPITAL REPORTED UNDERFILLING BD CITRATE TUBES (2,7 ML, REF 363079). BD KAM TESTED AND CONFIRMED THAT THE TUBES WERE UNDERFILLED WITH WATER AFTER STANDARD PROCEDURE OF TUBE CHECKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95542 BD VACUTAINER 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0094528

    Patients

    Seq Age Sex Outcome Treatment
    1