BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER MULTIPLE SAMPLE ADAPTER

    MDR report key: 8303262 · Received February 4, 2019

    Report

    Report Number
    2618282-2019-00121
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    December 24, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903649025
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD NOT RECEIVED ANY SAMPLE AND/OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. INVESTIGATION CONCLUSION: THERE WAS NO SAMPLES AND/OR PHOTOS AVAILABLE FOR EVALUATION. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED WITHIN THE SCOPE OF THIS EVALUATION. D WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE NO SAMPLES AND/OR PHOTOS WERE RECEIVED. ROOT CAUSE DESCRIPTION: DUE TO NO SAMPLES AND/ OR PHOTOS BEING RECEIVED, THE MANUFACTURING INVESTIGATION WAS LIMITED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. RATIONALE: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THERE WERE NO SAMPLES AND/OR PHOTOS SUBMITTED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER MULTIPLE SAMPLE ADAPTERS WERE UNABLE TO TAKE SAMPLES FROM THE PATIENT, RESULTING IN A REDRAW ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94734 BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER MULTIPLE SAMPLE ADAPTER BLOOD COLLECTION SET JKA BD CARIBE LTD. UNKNOWN 50382903649025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention