BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE

    MDR report key: 9638218 · Received January 28, 2020

    Report

    Report Number
    1917413-2020-00035
    Event Type
    Malfunction
    Date Received
    January 28, 2020
    Date of Event
    January 7, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903697149
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, 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 SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF OVERFILL DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 369714 BATCH NO. UNKNOWN (POSSIBLE LOTS 9158974, 9260646, 9220505) IT WAS REPORTED THAT THE TUBES ARE OVERFILLING VERBIAGE RECEIVED DURING PHONE CALL, - ALL THE TUBES IN THE PROVIDED LOTS ARE OVERFILLING DATE OF EVENT: (B)(6)2020 PATIENT IDENTIFIERS NOT AVAILABLE COMPLAINT (B)(4) OF (B)(4).

    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 #: 9158974, MEDICAL DEVICE EXPIRATION DATE: 2020-12-31, DEVICE MANUFACTURE DATE: 2019-06-07, MEDICAL DEVICE LOT #: 9260646, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2019-09-17, MEDICAL DEVICE LOT #: 9220505, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2019-08-08. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING THREE OCCURRENCES OF OVERFILL DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 369714 BATCH NO. UNKNOWN (POSSIBLE LOTS 9158974, 9260646, 9220505). IT WAS REPORTED THAT THE TUBES ARE OVERFILLING. VERBIAGE RECEIVED DURING PHONE CALL, - ALL THE TUBES IN THE PROVIDED LOTS ARE OVERFILLING. DATE OF EVENT: (B)(6) 2020. PATIENT IDENTIFIERS NOT AVAILABLE. COMPLAINT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103414 BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 369714 SEE H.10 50382903697149

    Patients

    Seq Age Sex Outcome Treatment
    1 Other