BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG

    MDR report key: 18007271 · Received October 25, 2023

    Report

    Report Number
    1917413-2023-01077
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 15, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627993
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF OCTOBER 2023. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 IS UNABLE TO BE CONFIRMED FOR GEL AIR BUBBLES. 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

    H3. 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 THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG, THERE WERE AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR BLOOD DONATION TEAMS ARE ISOLATING EFFECTED TUBES THAT THEY IDENTIFY WITHIN THE STOCK FOUND IN THEIR STOCKS ON A DAILY BASIS AND ALTHOUGH NUMBERS ARE STILL LOW, AIR IN GEL HAS NOW BEEN SEEN IN THE FOLLOWING LOTS: 2321329, 3111753, 3111754, 3111755, 3111756.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG, THERE WERE AIR BUBBLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR BLOOD DONATION TEAMS ARE ISOLATING EFFECTED TUBES THAT THEY IDENTIFY WITHIN THE STOCK FOUND IN THEIR STOCKS ON A DAILY BASIS AND ALTHOUGH NUMBERS ARE STILL LOW, AIR IN GEL HAS NOW BEEN SEEN IN THE FOLLOWING LOTS: 2321329, 3111753, 3111754, 3111755, 3111756.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048818 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 15.8 MG BLOOD SPECIMEN COLLECTION DEVICE PJE BECTON, DICKINSON & CO. (BROKEN BOW) 3111754 50382903627993

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown