BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBER INFLATION DEVICE

    MDR report key: 7438875 · Received April 17, 2018

    Report

    Report Number
    2020394-2018-00402
    Event Type
    Malfunction
    Date Received
    April 17, 2018
    Date of Event
    March 1, 2018
    Report Date
    August 31, 2018
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    MAV
    UDI-DI
    00801741090721
    PMA / PMN Number
    K042449
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS REQUESTED; AT THIS TIME THE RESULTS OF THE MANUFACTURING REVIEW HAVE NOT BEEN PROVIDED BY PEROUSE MEDICAL. LABELING REVIEW: THE REVIEW OF THE IFU (INSTRUCTIONS FOR USE), INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS NOT SENT TO THE MANUFACTURING SITE FOR EVALUATION, BASED ON INSTRUCTION RECEIVED FROM THE MANUFACTURING SITE. THE DEVICE WAS VISUALLY INSPECTED ON-SITE, AND A CRACK WAS NOTED IN THE TRAY AT THE HANDLE-END OF THE PACKAGING. NO DEFECTS WERE NOTED TO THE TYVEK LID OR SEAL. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BREACH OF STERILE BARRIER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ALLEGED BREAK IN THE STERILE BARRIER. THERE WAS NO PATIENT CONTACT.

    Additional Manufacturer Narrative · 1

    NO MEDICAL RECORDS OR NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALLEGED BREAK IN THE STERILE BARRIER. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279585 CALIBER INFLATION DEVICE INFLATION DEVICE MAV BARD PERIPHERAL VASCULAR, INC. 15085513 00801741090721

    Patients

    Seq Age Sex Outcome Treatment
    1