BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ ACCESS DEVICE

    MDR report key: 16372360 · Received February 14, 2023

    Report

    Report Number
    2618282-2023-00011
    Event Type
    Malfunction
    Date Received
    February 14, 2023
    Date of Event
    November 22, 2022
    Report Date
    March 17, 2023
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903649025
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 36490200 LOT/BATCH #: 2243459 BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WERE REVIEWED AND THE INDICATED FAILURE MODE OF BENT HUB WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 48 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION, AND 12 WERE EVALUATED BY FUNCTIONAL TESTING. NO ISSUES WERE OBSERVED RELATING TO BENT HUB 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 BENT HUB. 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 LUER-LOK¿ ACCESS DEVICE THE TUBE WAS UNABLE TO BE FILLED COMPLETELY. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LLAD CANNULA CAUSED IN SIDEWALL PUNCTURE OF THE CPT PRODUCT RESULTING IN A LOW DRAW. OUT OF 450 DRAWS USING THE GUIDED DRAW SYSTEM, 8 SIDEWALL PUNCTURES OCCURRED DURING TEST METHOD DEVELOPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ ACCESS DEVICE THE TUBE WAS UNABLE TO BE FILLED COMPLETELY. THIS EVENT OCCURRED 8 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LLAD CANNULA CAUSED IN SIDEWALL PUNCTURE OF THE CPT PRODUCT RESULTING IN A LOW DRAW. OUT OF 450 DRAWS USING THE GUIDED DRAW SYSTEM, 8 SIDEWALL PUNCTURES OCCURRED DURING TEST METHOD DEVELOPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681715 BD LUER-LOK¿ ACCESS DEVICE BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 364902 2243459 50382903649025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown