BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 18275214 · Received December 6, 2023

    Report

    Report Number
    2243072-2023-02143
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    00382903672837
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MATERIAL #: 367283 LOT/BATCH #: 23D22B1 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 50 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND ANOTHER 8 RETENTION SAMPLES BY FUNCTIONAL SAFETY SHIELD TESTING, AND NO ISSUES WERE OBSERVED RELATING TO DIFFICULT TO ACTIVATE SAFETY SHIELD 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 MODE DIFFICULT TO ACTIVATE SAFETY SHIELD. 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. H3 OTHER TEXT : SEE H.10

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS PLAINFIELD, IN. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. G5: PMA/510(K)#: ONE ADDITIONAL CODE APPLIES: K991088 H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD DID NOT SLIDE ON NEEDLE RESULTING IN A NEEDLESTICK INJURY AND THIS EVENT OCCURRED 1 TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, THE SAFETY SHIELD DID NOT SLIDE ON NEEDLE RESULTING IN A NEEDLESTICK INJURY AND THIS EVENT OCCURRED 1 TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072244 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 23D22B1 00382903672837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown