BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBER INFLATION DEVICE

    MDR report key: 6591162 · Received May 25, 2017

    Report

    Report Number
    2020394-2017-00515
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    May 5, 2017
    Report Date
    September 27, 2017
    Manufacturer
    PEROUSE MEDICAL
    Product Code
    MAV
    UDI-DI
    00801741090721
    PMA / PMN Number
    K042449
    Removal / Correction Number
    Z-1891-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    BARD PERIPHERAL VASCULAR AS THE DISTRIBUTOR OF THIS PRODUCT FILED AN EMDR ON BEHALF OF THE LEGAL MANUFACTURER (PEROUSE MEDICAL) FOR THE ALLEGED BREACH OF STERILE BARRIER. A DECISION WAS MADE BY TO FILE ON BEHALF OF PEROUSE AS A PRECAUTIONARY MEASURE. THE REGISTRATION NUMBER FOR PEROUSE MEDICAL IS #(B)(4). NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. HOWEVER, A PHOTO OF THE DEVICE HAS BEEN PROVIDED. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT 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.

    Additional Manufacturer Narrative · 1

    BARD PERIPHERAL VASCULAR AS THE DISTRIBUTOR OF THIS PRODUCT FILED AN EMDR ON BEHALF OF THE LEGAL MANUFACTURER (PEROUSE MEDICAL) FOR THE ALLEGED BREACH OF STERILE BARRIER. A DECISION WAS MADE BY TO FILE ON BEHALF OF PEROUSE AS A PRECAUTIONARY MEASURE. THE REGISTRATION NUMBER FOR PEROUSE MEDICAL IS #3002504068. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS REQUESTED; AT THIS TIME THE RESULTS OF THE MANUFACTURING REVIEW HAVE NOT BEEN PROVIDED BY PEROUSE MEDICAL. CONCLUSION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THREE PHOTOS WERE PROVIDED FOR REVIEW. A CRACK CAN BE IDENTIFIED IN EACH OF THE PROVIDED PHOTOS. THEREFORE, THE INVESTIGATION CAN BE CONFIRMED FOR A PACKAGING ISSUE. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. PEROUSE MEDICAL BELIEVES THE ISSUE IS RELATED TO A CHANGE IN FACILITY FOR THE PACKAGING OF THE DEVICE. PEROUSE MEDICAL IS INVESTIGATING THE ISSUE THROUGH A CAPA. A RECALL WAS INITIATED FOR ALL LOTS BELIEVED TO BE EFFECTED. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNING: CONTENTS SUPPLIED STERILE USING ETHYLENE OXIDE (EO). NON-PYROGENIC. DO NOT USE IF STERILE BARRIER IS OPENED OR DAMAGED. SINGLE PATIENT USE ONLY. DO NOT REUSE, REPROCESS OR RE-STERILIZE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALLEGED CRACK WAS OBSERVED ON THE PLASTIC PACKAGING OF THE INFLATION DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALLEGED CRACK WAS OBSERVED ON THE PLASTIC PACKAGING OF THE INFLATION DEVICE. THERE WAS NO REPORTED PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372092 CALIBER INFLATION DEVICE ANGIOGRAPHIC INJECTOR AND SYRINGE MAV PEROUSE MEDICAL 16025640 00801741090721

    Patients

    Seq Age Sex Outcome Treatment
    1