BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LHK,US,CENTRA STATE HEALTHCARE

    MDR report key: 20043197 · Received August 22, 2024

    Report

    Report Number
    3015910259-2024-00031
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 25, 2024
    Report Date
    August 23, 2024
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    OES
    UDI-DI
    40195327513017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON 7/25, "LHK WAS BEING SET UP FOR A CASE AND IT WOULDN'T TIGHTEN. IT SEEMED LIKE IT WAS THE SYRINGE CONNECTION. THE STAFF RELAYED THE DEFECT A FEW DAYS AFTER THEY THREW THE MANIFOLD AWAY AND REPLACED IT WITH A NEW ONE WITH NO OTHER INCIDENTS. THIS OCCURRED PRIOR TO USE- WHEN PREPPING THE MANIFOLD FOR THE CASE. THERE WAS NO PATIENT INVOLVEMENT, NO IMPACT TO THE PATIENT, AND THE PROCEDURES WERE COMPLETED". MULTIPLE INSTANCES WERE REPORTED BY THE FACILITY, HOWEVER AT THIS TIME A DEFINITIVE NUMBER WAS NOT PROVIDED. THIS MEDWATCH WILL ACCOUNT FOR ALL REPORTED INCIDENCES. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN (B)(6) ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    UPDATED H6: INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON 7/25, "LHK WAS BEING SET UP FOR A CASE AND IT WOULDN'T TIGHTEN. IT SEEMED LIKE IT WAS THE SYRINGE CONNECTION. THE STAFF RELAYED THE DEFECT A FEW DAYS AFTER THEY THREW THE MANIFOLD AWAY AND REPLACED IT WITH A NEW ONE WITH NO OTHER INCIDENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071991 LHK,US,CENTRA STATE HEALTHCARE OES MEDLINE INDUSTRIES, LP 24EBP218 40195327513017

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female