BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 21332842 · Received February 7, 2025

    Report

    Report Number
    1917413-2025-00078
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 10, 2025
    Report Date
    February 27, 2025
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    30382903627883
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBERS ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4166334. D4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2025. H4. DEVICE MANUFACTURE DATE: 14-JUN-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #: 4137980. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. H4. DEVICE MANUFACTURE DATE: 16-MAY-2024. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION: YES. H3. DEVICE EVAL BY MANUFACTURER? YES. D9. RETURNED TO MANUFACTURER ON: 13-FEB-2025. INVESTIGATION SUMMARY: BD RECEIVED 50 SAMPLES AND 6 PHOTOS FOR INVESTIGATION RELATED TO LOT NUMBERS 4102173, 4137980, AND 4166334. THE VISUAL INSPECTION OF THE SAMPLES AND EVALUATION OF THE PHOTOS REVEALED LARGE DROPLETS OF ADDITIVE ON THE INSIDE WALL OF THE TUBES, DIFFERING FROM THE TYPICAL DOT PATTERN EXPECTED FOR THIS TUBE TYPE. ADDITIONALLY, THE PRESENCE OF FOREIGN MATERIAL (FM) WAS NOTED BOTH OUTSIDE AND INSIDE THE TUBES, CHARACTERIZED BY BLACK AND WHITE PARTICLES. ANOTHER OBSERVATION WAS EMBEDDED FM IN THE TUBE SIDEWALLS, APPEARING AS BLACK SPECKS. THIS EMBEDDED FM IS CONSIDERED A COSMETIC DEFECT, OFTEN RESULTING FROM RESIN COLORANT OR RESIN ADHERING TO THE INTERIOR OF THE MOLD CORE DURING PRODUCTION STARTS OR RESTARTS AFTER MAINTENANCE. THE EXACT CAUSES FOR THE CUSTOMER¿S REPORTED FAILURE MODES COULD NOT BE DETERMINED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR: ADDITIVE ABNORMALITY, FOREIGN MATTER - NON-BIOLOGICAL AND MOLDING DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER (FM) OR AN ADDITIVE ABNORMALITY (WHITE MASS-LIKE ADDITIVE ABNORMALITY). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, AN UNSPECIFIED NUMBER OF TUBES CONTAINED FOREIGN MATTER (FM) OR AN ADDITIVE ABNORMALITY (WHITE MASS-LIKE ADDITIVE ABNORMALITY). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247319 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 4102173 30382903627883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown