BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR

    MDR report key: 8707774 · Received June 18, 2019

    Report

    Report Number
    1640201-2019-00033
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 21, 2019
    Report Date
    June 18, 2019
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    MAL
    UDI-DI
    00384401017684
    PMA / PMN Number
    K954848
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS INSPECTED BY OUR QUALITY ASSURANCE (QA) MANAGER FOR AN EVALUATION OF THE PACKAGING COMPONENTS. HIS OBSERVATIONS ARE AS FOLLOWS: ONE TAMPER-EVIDENT LABELS ON THE PRODUCT BOX IS OPENED. THERE IS A MATCH BETWEEN THE LABELING OF THE BOX, THE PATIENT LABELS AND THE GRAFT SIZER INSIDE. HOWEVER, THE PRODUCT IN THE PRIMARY PACKAGING AND ITS LABELING (MODEL # M002020952120, LOT # 25081421) DO NOT CORRESPOND TO THE EXTERNAL BOX LABELING. IN CONCLUSION, THE PRODUCT DOES NOT COMPLY WITH THE SPECIFICATIONS DUE TO A LABELING DISCREPANCY. THE GRAFT CORRESPONDING TO THE PRODUCT BOX LABELING WAS MANUFACTURED ON SEPTEMBER 2017 BY INTERVASCULAR SAS IN (B)(6), IT WAS DELIVERED TO (B)(6) MEDICAL CENTER ON JANUARY 2018. THE GRAFT IN THE PRIMARY PACKAGING THAT WAS FOUND INSIDE THE PRODUCT BOX WAS MANUFACTURED ON JULY 2013 BY MAQUET CARDIOVASCULAR LLC IN THE UNITED STATES AND WAS DELIVERED TO (B)(6) MEDICAL CENTER ON MARCH 2014. THEREFORE, IT IS ASSUMED THAT THE PACKAGING TRANSFER OCCURRED DURING STORAGE AT THE HOSPITAL. THE MOST LIKELY CAUSE OF THIS EVENT IS A PACKAGING MIX-UP DURING STORAGE AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT INSIDE THE PRODUCT BOX DID NOT MATCH THE BOX LABELING. THE PRODUCT WAS NEVER OPENED OR IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500371 HEMASHIELD GOLD KNITTED MICROVEL DOUBLE VELOUR GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE MAL INTERVASCULAR SAS M002020851260 17J13 00384401017684

    Patients

    Seq Age Sex Outcome Treatment
    1