BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 21403641 · Received February 18, 2025

    Report

    Report Number
    1917413-2025-00130
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 23, 2025
    Report Date
    February 28, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, 94 RETENTION SAMPLES FROM LOT 4102173 AND 80 RETENTION SAMPLES FROM LOT 4137980 WERE VISUALLY INSPECTED WITH GEL AIR BUBBLES OBSERVED IN 2 AND 1 TUBES RESPECTIVELY. 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. AIR BUBBLES IN GEL ARE SEEN WHEN AIR POCKETS ARE IN THE GEL MATERIAL OR IF AIR IS INTRODUCED INTO THE LINES DURING THE DISPENSE PROCESS. THERE ARE PURGES THAT ALLOW THE OPERATORS TO MINIMIZE THE AMOUNT OF AIR BUBBLES PRODUCED FROM AIR IN THE LINES, AND INSPECTIONS THAT MINIMIZE THE NUMBER OF TUBES RELEASED THAT HAVE AIR BUBBLES CAUSED BY THE AIR POCKETS. IF SMALL BUBBLES ARE PRESENT IN GEL PRODUCT WHEN THE PRODUCT IS STERILIZED, THESE BUBBLES BECOME LARGER DUE TO THE HEAT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE GEL AIR BUBBLES. BD WAS NOT ABLE TO IDENTIFY AN EXACT 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

    E1.INITIAL REPORTER ADDR 1: E1.INITIAL REPORTER PHONE #: (B)(6) THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4102173 D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025 H4. DEVICE MANUFACTURE DATE: 11-APR-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(6) 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, 430 TUBES CONTAINED GEL AIR BUBBLES. 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, 430 TUBES CONTAINED GEL AIR BUBBLES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41980 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 4137980 30382903627883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown