BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 16653031 · Received March 30, 2023

    Report

    Report Number
    1917413-2023-00245
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 21, 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

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG GEL SMEARING AND POOR BARRIER SEPARATED OCCURRED WITH 40 TUBES. 20 WITH EACH WITH LOTS 2080603 AND 2132044. THERE WAS NO REPORT OF PATIENTS OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BLOOD COLLECTION TUBE HANGING ON THE WALL. PHOTOS REVEAL GEL SMEARING.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT THREE PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL SMEARING AND POOR BARRIER SEPARATION WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, THE INDICATED FAILURE MODE FOR GEL SMEARING AND POOR BARRIER SEPARATION WAS NOT OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE THE CUSTOMER¿S INDICATED FAILURE MODES (GEL SMEARING, POOR BARRIER AND RBCS ON BARRIER) BECAUSE THE DEFECTS WERE NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. EVALUATION OF BOTH RETAIN AND CONTROL SAMPLES TESTED WAS ACCEPTABLE. ALL SAMPLES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. 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 SMEARING AND POOR BARRIER SEPARATION BASED ON PHOTOS ONLY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    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 #: 2080603, MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2023, DEVICE MANUFACTURE DATE: 21-MAR-2022. MEDICAL DEVICE LOT #: 2132044, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2023, DEVICE MANUFACTURE DATE: 12-MAY-2022. 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 DURING USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG GEL SMEARING AND POOR BARRIER SEPARATED OCCURRED WITH 40 TUBES. 20 WITH EACH WITH LOTS 2080603 AND 2132044. THERE WAS NO REPORT OF PATIENTS OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BLOOD COLLECTION TUBE HANGING ON THE WALL. PHOTOS REVEAL GEL SMEARING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG GEL SMEARING AND POOR BARRIER SEPARATED OCCURRED WITH 40 TUBES. 20 WITH EACH WITH LOTS 2080603 AND 2132044. THERE WAS NO REPORT OF PATIENTS OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BLOOD COLLECTION TUBE HANGING ON THE WALL, PHOTOS REVEAL GEL SMEARING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG GEL SMEARING OCCURRED WITH 40 TUBES. 20 WITH EACH WITH LOTS 2080603 AND 2132044. THERE WAS NO REPORT OF PATIENTS OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: BLOOD COLLECTION TUBE HANGING ON THE WALL. PHOTOS REVEAL GEL SMEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266010 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