BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES

    MDR report key: 18711474 · Received February 15, 2024

    Report

    Report Number
    9617032-2024-00192
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Date of Event
    January 24, 2024
    Report Date
    February 20, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903659006
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: (B)(6) 2024 H.6. INVESTIGATION SUMMARY: BD RECEIVED SIX SAMPLES FROM LOT# 3122406. THE RETURNED SAMPLES AND 5 PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODES OF FOREIGN MATTER, DAMAGED TUBE, AND ADDITIVE ABNORMALITY WERE OBSERVED. BD RECEIVED TWO SAMPLES FROM LOT# 3093771. THE RETURNED SAMPLES ALONG WITH THE PHOTOS WERE VISUALLY EVALUATED AND THE INDICATED FAILURE MODES OF DAMAGED TUBE AND EMBEDDED FM IN THE TUBE WALL WERE OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED. 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 HAS BEEN CONFIRMED ON LOT# 3122406 WITH RESPECT TO FOREIGN MATTER, DAMAGED TUBE, AND ADDITIVE ABNORMALITY. THIS COMPLAINT HAS BEEN CONFIRMED ON LOT# 3093771 WITH RESPECT TO EMBEDDED FOREIGN MATTER AND DAMAGED TUBE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3093771. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2024. H.4. DEVICE MANUFACTURE DATE: 03-APR-2023. D.4. MEDICAL DEVICE LOT #: 3122406. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEPT-2024. H.4. DEVICE MANUFACTURE DATE: 02-MAY-2023.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES THERE WERE TWO FOREIGN MATTER INSIDE THE TUBE, AND ONE WITH A CRACK TUBE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES THERE WERE TWO FOREIGN MATTER INSIDE THE TUBE, AND ONE WITH A CRACK TUBE. THERE WAS NO REPORT OF IMPACT TO PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541168 BD VACUTAINER® K2E 10.8MG PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10 30382903659006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown