BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES

    MDR report key: 15525463 · Received October 1, 2022

    Report

    Report Number
    9617032-2022-00966
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    September 23, 2022
    Report Date
    September 23, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "MATERIAL #: 367376. LOT/BATCH #: 2152349. BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER - INSECT WAS OBSERVED. BD WAS NOT ABLE TO DETERMINE WHERE OR WHEN THE INSECT MAY HAVE ENTERED THE TUBE. THE MANUFACTURING SITE UTILIZES PEST BAIT BOXES, ELECTRONIC FLYING INSECT KILLERS, AND IS VISITED BY A FIELD BIOLOGIST TWICE A YEAR TO REVIEW OUR SYSTEMS AND HELP PREVENT PESTS. ADDITIONALLY, (B)(4) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF FOREIGN MATTER - INSECT 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 FOREIGN MATTER - INSECT. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES CUSTOMER FOUND A FLY IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿FINDING A FLY IN THE TUBE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337056 BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2152349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown