BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA 2.0ML BLOOD COLLECTION TUBES

    MDR report key: 16287780 · Received February 2, 2023

    Report

    Report Number
    3003916417-2023-00014
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 7, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2023-03-03. H.6. INVESTIGATION SUMMARY: BD RECEIVED 7 SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT, 5 FROM BATCH 2273484 AND 2 FROM 2151171. THE SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 5 RETENTION SAMPLES FROM EACH LOT OF THE 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 ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2151171. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2023. DEVICE MANUFACTURE DATE: 23-JUN-2022. MEDICAL DEVICE LOT #: 2273484. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2023. DEVICE MANUFACTURE DATE:26-OCT-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 LOTS OF BD VACUTAINER® K2 EDTA 2.0ML BLOOD COLLECTION TUBES THE TUBES WERE UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT WAS IDENTIFIED IN A FOLLOW-UP VISIT THAT THE 2ML EDTA TUBES (360055), FROM DIFFERENT BATCHES, ARE NOT REACHING THE 2ML FILL MARK. IF TWO DIFFERENT BATCHES ARE COMPARED, IT IS OBSERVED THAT THE FILLING VOLUME OF THE TWO TUBES IS THE SAME, BUT IN NONE OF THEM THE FILLING MARK WAS REACHED. THE CUSTOMER SUGGESTED THE POSSIBILITY THAT THE VACUUM INJECTOR EQUIPMENT IN THE TUBES WAS OUT OF CALIBRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH 2 LOTS OF BD VACUTAINER® K2 EDTA 2.0ML BLOOD COLLECTION TUBES THE TUBES WERE UNDERFILLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: IT WAS IDENTIFIED IN A FOLLOW-UP VISIT THAT THE 2ML EDTA TUBES (360055), FROM DIFFERENT BATCHES, ARE NOT REACHING THE 2ML FILL MARK. IF TWO DIFFERENT BATCHES ARE COMPARED, IT IS OBSERVED THAT THE FILLING VOLUME OF THE TWO TUBES IS THE SAME, BUT IN NONE OF THEM THE FILLING MARK WAS REACHED. THE CUSTOMER SUGGESTED THE POSSIBILITY THAT THE VACUUM INJECTOR EQUIPMENT IN THE TUBES WAS OUT OF CALIBRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347822 BD VACUTAINER® K2 EDTA 2.0ML BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown