BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 17545093 · Received August 14, 2023

    Report

    Report Number
    1917413-2023-00787
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 24, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627993
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WAS OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JULY 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT HAS BEEN CONFIRMED FOR POOR BARRIER SEPARATION. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. E.1. INITIAL REPORTER PHONE #:(B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4 DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    REPORT 1 OF 5: IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF ONE PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS: B03872364205822. ON 09 JUNE 2023 IT WAS NOTICED AT THE CSL PLASMA LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT 131700 FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED. DATE OF RECEIPT AT CSL PLASMA LABORATORY WAS 07 JUNE 2023."

    Description of Event or Problem · 0

    REPORT 1 OF 5: IT WAS REPORTED THAT WHILE USING BD VACUTAINER PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE IS POOR BARRIER SEPARATION OF ONE PATIENT SAMPLE. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAMPLE NUMBERS: (B)(6). ON (B)(6) 2023, IT WAS NOTICED AT THE CSL PLASMA LABORATORY THAT THE GEL BARRIERS OF 90% OF THE TEST TUBES OF SHIPMENT 131700 FROM A BELGIUM PLASMA SUPPLIER WERE POORLY FORMED. DATE OF RECEIPT AT CSL PLASMA LABORATORY WAS 07 JUNE 2023."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55390 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) UNKNOWN 50382903627993

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown