BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASCULAR GRAFT

    MDR report key: 5051582 · Received September 2, 2015

    Report

    Report Number
    2242352-2015-01031
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MAQUET CV
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2015 04:56 PM (GMT-5:00) ADDED BY (B)(4): THE ROOT CAUSE IS USER ERROR AS REPORTED BY THE ACCOUNT IN A FOLLOWUP E-MAIL. THE ACCOUNT STATES THAT THE PRODUCT WAS INADVERTENTLY PLACED IN THE WRONG BOX BY THE USER. (B)(4) 2015 04:27 PM (GMT-5:00) ADDED BY (B)(4). THE PRODUCT WAS RETURNED TO THE FACTORY FOR EVALUATION. THERE WAS NO EVIDENCE OF BLOOD. THE OUTER BOX SHOWED LABELING FOR UPN M002020954080, LOT 25085720. THE INNER BLISTER PACK SHOWED LABELING FOR UPN M002020951060 LOT 25074913. BASED ON THE CONDITION OF THE DEVICE AS FOUND, THE REPORTED COMPLAINT WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    SEPTEMBER 01, 2015 12:22 PM (GMT-4:00) ADDED BY (B)(6): THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THERE WAS A DIFFERENT PRODUCT INSIDE THE BOX THAN WHAT WAS STATED ON THE BOX. THEY ORDERED HEMASHIELD MDV GRAFTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THERE WAS A DIFFERENT PRODUCT INSIDE THE BOX THAN WHAT WAS STATED ON THE BOX. THEY ORDERED HEMASHIELD MDV GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582025 VASCULAR GRAFT GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE MAL MAQUET CV 8 MM 30CM HEMASHIELD MDV 25085720

    Patients

    Seq Age Sex Outcome Treatment
    1