BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBES

    MDR report key: 17487084 · Received August 9, 2023

    Report

    Report Number
    1024879-2023-00549
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    July 20, 2023
    Report Date
    August 30, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903678148
    PMA / PMN Number
    BK050036
    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: MATERIAL #: 367814. LOT/BATCH #: 2181492. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR CRACKED PRODUCT WAS OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF CRACKED PRODUCT WAS NOT 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 CRACKED PRODUCT. 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WAS A CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHASE: WHEN THE PRODUCT IS IN USE. DEFECT; RUPTURE OF BLOOD COLLECTION TUBE. QUANTITY: (B)(4). EFFECTS: NO OTHER ADVERSE EFFECTS ON PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SERUM BLOOD COLLECTION TUBES THAT THERE WAS A CRACKED TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHASE: WHEN THE PRODUCT IS IN USE. DEFECT; RUPTURE OF BLOOD COLLECTION TUBE. QUANTITY: 1; EFFECTS: NO OTHER ADVERSE EFFECTS ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544169 BD VACUTAINER® SERUM BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 2181492 50382903678148

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown