BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR

    MDR report key: 8260461 · Received January 18, 2019

    Report

    Report Number
    1640201-2019-00005
    Event Type
    Malfunction
    Date Received
    January 18, 2019
    Report Date
    April 8, 2019
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    MAL
    UDI-DI
    00384401017691
    PMA / PMN Number
    K954848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (10/3221) DESPITE REPETITIVE EFFORTS, THE INVOLVED PRODUCT WAS NEVER RETURNED TO INTERVASCULAR FOR AN EVALUATION OF THE PACKAGING COMPONENTS. DEVICE NOT AVAILABLE FOR EVALUATION HAS BEEN MODIFIED ACCORDINGLY (4308) THE MOST LIKELY CAUSE OF THIS EVENT IS A PACKAGING MIX-UP DURING STORAGE AT THE CONSIGNMENT STOCK.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR CONTENT EXAMINATION. THE GRAFT CORRESPONDING TO THE PRODUCT BOX LABELING WAS MANUFACTURED ON AUGUST 2015 BY INTERVASCULAR (B)(4) IN (B)(6), IT WAS DELIVERED TO THE CONSIGNMENT STOCK AT (B)(6) HOSPITAL ON (B)(6) 2016. THE GRAFT THAT WAS FOUND INSIDE THE PRODUCT BOX WAS MANUFACTURED BY MAQUET CARDIOVASCULAR LLC IN THE UNITED STATES AND WAS DELIVERED TO THE CONSIGNMENT STOCK AT (B)(6) HOSPITAL ON (B)(6) 2014. THEREFORE, IT IS ASSUMED THAT THE PACKAGING TRANSFER OCCURRED DURING STORAGE AT THE CONSIGNMENT STOCK. THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    STAFF OPENED THE BOX AND NOTICED THAT THE GRAFT INSIDE DID NOT MATCH THE BOX LABELING. THEY THOUGHT THEY WERE OPENING A GRAFT WHOSE DIMENSIONS WERE 12MMX7MMX40CM, INSTEAD THEY FOUND A GRAFT WHOSE DIMENSIONS WERE 14MMX7MMX40CM. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT WAS INVOLVED. IT WAS REPORTED THAT THE EVENT OCCURRED SOME TIME AGO BUT THERE WAS A REPORTING OMISSION. THE EVENT DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55280 HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR VASCULAR POLYESTER GRAFT MAL INTERVASCULAR SAS M002020851270 15H26 00384401017691

    Patients

    Seq Age Sex Outcome Treatment
    1