BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 16330802 · Received February 9, 2023

    Report

    Report Number
    1917413-2023-00106
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 13, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627887
    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

    H.6. INVESTIGATION SUMMARY:BD HAD NOT RECEIVED SAMPLES, BUT 9 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES 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 THE INDICATED FAILURE MODE GEL AIR BUBBLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. SEE H.10.

    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 #: 2109020, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2023, AND DEVICE MANUFACTURE DATE: 15-JUN-2022. MEDICAL DEVICE LOT #: 2132044, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023, AND DEVICE MANUFACTURE DATE: 12-MAY-2022. MEDICAL DEVICE LOT #: 2166964, MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2023, AND DEVICE MANUFACTURE DATE: 15-JUN-2022. DEVICE EVALUATED BY MFR: 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 PRIOR TO USE WITH 3 LOTS OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AIR BUBBLES IN GEL WAS DISCOVERED. THIS OCCURRED WITH 355 TUBES OF LOT# 2109020, 219 WITH LOT# 2132044 AND 592 TUBES OF LOT# 2166964. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ABNORMAL BUBBLES APPEAR IN THE SEPARATION GEL AT THE BOTTOM OF THE BLOOD COLLECTION TUBE QUANTITY: 1166 PIECES EFFECTS: NO EFFECT ON PATIENTS AND USERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 3 LOTS OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AIR BUBBLES IN GEL WAS DISCOVERED. THIS OCCURRED WITH 355 TUBES OF LOT# 2109020, 219 WITH LOT# 2132044 AND 592 TUBES OF LOT# 2166964. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ABNORMAL BUBBLES APPEAR IN THE SEPARATION GEL AT THE BOTTOM OF THE BLOOD COLLECTION TUBE. QUANTITY: 1166 PIECES EFFECTS: NO EFFECT ON PATIENTS AND USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607456 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 SEE H.10 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown