BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PVS SINGLE USE ACC.KIT MICS SIZE M

    MDR report key: 8097838 · Received November 21, 2018

    Report

    Report Number
    3005687633-2018-00215
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 23, 2018
    Report Date
    January 18, 2019
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    LWR
    PMA / PMN Number
    P150011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THIS ISSUE IT WAS DETERMINED THAT THE ROOT CAUSE OF THE MISLABELING WAS A MANUFACTURING ISSUE WHICH OCCURRED DURING THE ASSEMBLING AND VISUAL QUALITY CONTROL INSPECTION OF THE ACCESSORY KIT. THE MANUFACTURER HAS ISSUED A FORMAL INQUIRY WAS INITIATED FOR THIS SPECIFIC EVENT TO DETERMINE WHICH ELEMENT OF THE QC INSPECTION LEAD TO THIS ERROR. IN ADDITION A RETRAINING OF THE SECTION OF THE PROCEDURE WHERE THE ISSUE OCCURRED HAS BEEN PERFORMED.

    Additional Manufacturer Narrative · 0

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE ACCESSORY HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE ACCESSORY SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE WAS RECEIVED BY THE MANUFACTURER ON NOV 8, 2018. A GROSS INVESTIGATION WAS PERFORMED ON THE RETURNED DEVICE. THE RETURNED ACCESSORIES WERE RECEIVED IN GENERAL GOOD CONDITIONS. CONFIRMATION OF WHAT WAS REPORTED BY THE FIELD. THE LABEL ON THE HANDLE OF THE BLUE HOLDER INDICATES A L/XL SIZE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 A PATIENT RECEIVED A PERCEVAL PVS23 SUTURELESS VALVE IMPLANT. THE NURSING STAFF OPENED A MEDIUM SIZE ACCESSORY KIT WHICH HAPPENED TO HAVE A L/XL VALVE HOLDER INCLUDED IN IT RATHER THAN THE PROPER S/M SIZE. A NEW ACCESSORY KIT WAS OPENED AND THE CASE PROCEEDED WITHOUT INCIDENT. AT THIS TIME IT IS NOT KNOWN IF THE ISSUE WITH THE HOLDER WAS IDENTIFIED PRIOR TO IT BEING OPENED INTO THE STERILE FIELD OR NOT. PER INFORMATION FROM A NURSE WHO WAS CIRCULATING THAT DAY IT WAS CONFIRMED THAT THE TAPE ON THE OUTSIDE OF THE BOX WAS STILL IN PLACE PRIOR TO HER OPENING IT AND THAT IT DID NOT APPEAR TO HAVE BEEN OPENED PRIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934200 PVS SINGLE USE ACC.KIT MICS SIZE M TISSUE HEART VALVES ACCESSORY LWR SORIN GROUP ITALIA S.R.L. 1804050057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other