BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBER INFLATION DEVICE

    MDR report key: 6234640 · Received January 9, 2017

    Report

    Report Number
    2020394-2016-01243
    Event Type
    Malfunction
    Date Received
    January 9, 2017
    Date of Event
    December 15, 2016
    Report Date
    May 25, 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
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. ONE PHOTO OF THE SAMPLE HAS BEEN MADE AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL/MICROSCOPIC INSPECTION: THE DEVICE APPEARED CLEANED. THE TYVEK SEAL IS INTACT. A CRACK WAS NOTED IN THE CLEAR PLASTIC OF THE PACKAGING. THE CRACK WAS NOTED NEAR THE HANDLE OF THE DEVICE. NO OTHER DAMAGE WAS NOTED TO THE PACKAGING. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. PHOTO REVIEW: ONE DIGITAL PHOTO WAS REVIEWED. THE PHOTO SHOWS WHAT APPEARS TO BE A CALIBER INFLATION DEVICE INSIDE OF PACKAGING. A CRACK IN THE PACKAGING CAN BE SEEN NEAR THE HANDLE OF THE DEVICE. BASED ON THE PROVIDED PHOTO THE INVESTIGATION CAN BE CONFIRMED FOR A PACKAGING ISSUE. CONCLUSION: THE DEVICE WAS RETURNED. BASED ON THE RETURN CONDITION, THE INVESTIGATION IS CONFIRMED FOR BREAK OF STERILE BARRIER DUE TO A PACKAGING ISSUE. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. 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. 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

    (B)(4). MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. VISUAL/MICROSCOPIC INSPECTION: THE DEVICE APPEARED CLEANED. THE TYVEK SEAL IS INTACT. A CRACK WAS NOTED IN THE CLEAR PLASTIC OF THE PACKAGING. THE CRACK WAS NOTED NEAR THE HANDLE OF THE DEVICE. NO OTHER DAMAGE WAS NOTED TO THE PACKAGING. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. PHOTO REVIEW: ONE DIGITAL PHOTO WAS REVIEWED. THE PHOTO SHOWS WHAT APPEARS TO BE A CALIBER INFLATION DEVICE INSIDE OF PACKAGING. A CRACK IN THE PACKAGING CAN BE SEEN NEAR THE HANDLE OF THE DEVICE. BASED ON THE PROVIDED PHOTO THE INVESTIGATION CAN BE CONFIRMED FOR A PACKAGING ISSUE. CONCLUSION: THE DEVICE WAS RETURNED. BASED ON THE RETURN CONDITION, THE INVESTIGATION IS CONFIRMED FOR BREAK OF STERILE BARRIER DUE TO A PACKAGING ISSUE. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. 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. (B)(4). 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 AN ALLEGED CRACK WAS OBSERVED ON SIDE OF THE PLASTIC PACKAGING OF THE INFLATION DEVICE. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18325 CALIBER INFLATION DEVICE ANGIOGRAPHIC INJECTOR AND SYRINGE MAV PEROUSE MEDICAL 15085181 00801741090721

    Patients

    Seq Age Sex Outcome Treatment
    1