BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1221934-2018-52920

    MDR report key: 7809024 · Received August 23, 2018

    Report

    Report Number
    1221934-2018-52920
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Report Date
    February 13, 2014
    PMA / PMN Number
    K951702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVALUATION STATEMENT: THE COMPLAINT DEVICE WAS RECEIVED AND INSPECTED. THERE ARE MISSING PARTS ON THE LOCK OF THE DEVICE. THE D-TENT, SPRING THAT HOLDS THE PIN IN PLACE AND THE PIN ARE MISSING, CONFIRMING THIS COMPLAINT. AT THIS POINT, A ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED FAILURE. BUT IT IS A POSSIBILITY THAT THE PARTS WERE MISPLACED DURING CLEANING WHERE THE DEVICE HAS TO BE TAKEN APART. MOREOVER, THE DEVICE APPEARS TO HAVE BEEN HEAVILY USED AS THE INFLOW AND OUTFLOW VALVES ARE CORRODED. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A BATCH HISTORY REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. (B)(4). THE LOT NUMBER IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THEIR LINVATEC HIGH FLOW SHEATH WAS BROKEN. THE BIOMED DID NOT HAVE FURTHER INFORMATION BUT CONFIRMED THAT THERE WAS NO PATIENT CONSEQUENCES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patients

    Seq Age Sex Outcome Treatment
    1