BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 20321986 · Received September 27, 2024

    Report

    Report Number
    1917413-2024-00908
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    30382903627951
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 10-OCT-2024. INVESTIGATION SUMMARY: BD RECEIVED 14 SAMPLES FROM LOT # 4045998 FOR INVESTIGATION. NO CUSTOMER RETURN SAMPLES WERE RECEIVED FOR LOT #'S 3289111 AND 4073675. RETURNED SAMPLE TESTING: THE RETURNED SAMPLES FOR LOT 4045998 WERE VISUALLY INSPECTED AND GEL AIR BUBBLES AND FOREIGN MATTER (FM) WAS OBSERVED. RETENTION SAMPLE TESTING: VISUAL EXAMINATION OF 100 TUBES FROM EACH LOT WAS PERFORMED: 100 RETENTIONS FROM LOT 3289111 WERE VISUALLY INSPECTED WITH 8 TUBES HAVING A LARGE BUBBLE IN THE GEL, NO FM WAS OBSERVED. 100 RETENTIONS FROM LOT 4045998 WERE VISUALLY INSPECTED WITH NO ISSUES BEING OBSERVED. 100 RETENTIONS FROM LOT 4073675 WERE VISUALLY INSPECTED WITH 1 TUBE HAVING A LARGE BUBBLE, NO FM WAS 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 FOR GEL AIR BUBBLES ON LOT #'S 3289111 AND 4073675 BASED ON RETENTION SAMPLE TESTING AND ON LOT 4045998 BASED ON RETURNED SAMPLE TESTING. THIS COMPLAINT HAS BEEN CONFIRMED FOR FM ON LOT # 4045998 BASED ON THE RETURNED SAMPLE TESTING. THIS COMPLAINT IS NOT CONFIRMED FOR FM FOR LOT #'S 3289111 AND 4073675. 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.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3289111, D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024, H4. DEVICE MANUFACTURE DATE: 16-OCT-2023. D4. MEDICAL DEVICE LOT #: 4045998, D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025, H4. DEVICE MANUFACTURE DATE: 14-FEB-2024. 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 · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AN UNSPECIFIED NUMBER OF TUBES HAD GEL AIR BUBBLES AND/OR FOREIGN MATTER(FM). 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 HAD GEL AIR BUBBLES AND/OR FOREIGN MATTER(FM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371852 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 4073675 30382903627951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown