BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H.11

    MDR report key: 19977449 · Received August 13, 2024

    Report

    Report Number
    1111096-2024-00001
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 14, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903679608
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MDR SUBMITTED WITH MFR REPORT #: 1111096-2024-00001 WAS GENERATED WITH THE INCORRECT SITE REGISTRATION NUMBER. THIS MDR IS NOW VOID AND AN MDR WITH THE CORRECT MFR NUMBER LINKED TO THE SITE REGISTRATION NUMBER WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 56 UNITS BLOOD COLLECTION TUBES THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3348910 D4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024 H4. DEVICE MANUFACTURE DATE: 14-DEC-2023 D4. MEDICAL DEVICE LOT #: 4045276 D4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2025 H4. DEVICE MANUFACTURE DATE: 14-FEB-2024 INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, RETENTION SAMPLES FROM BD INVENTORY OF EACH REPORTED LOT NUMBER WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER OR GEL AIR BUBBLES AS ALL SAMPLES MET SPECIFICATIONS. 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 THE INDICATED FAILURE MODES FOREIGN MATTER OR GEL AIR BUBBLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODES. 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 PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 56 UNITS BLOOD COLLECTION TUBES THAT AN UNSPECIFIED NUMBER OF TUBES CONTAINED AIR BUBBLES IN THE GEL AND FOREIGN MATTER IN THE TUBE WALL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 56 UNITS BLOOD COLLECTION TUBES THAT AN UNSPECIFIED NUMBER OF TUBES CONTAINED AIR BUBBLES IN THE GEL AND FOREIGN MATTER IN THE TUBE WALL. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518593 SEE H.11 BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) SEE H.11 30382903679608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown