BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIBER INFLATION DEVICE

    MDR report key: 6248275 · Received January 12, 2017

    Report

    Report Number
    2020394-2016-01266
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 20, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO HOSPITAL/MEDICAL RECORDS OR 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.

    Additional Manufacturer Narrative · 1

    BARD PERIPHERAL VASCULAR AS THE DISTRIBUTOR OF THIS PRODUCT FILED AN EMDR ON BEHALF OF THE LEGAL MANUFACTURER (B)(4) FOR THE ALLEGED BREACH OF STERILE BARRIER. A DECISION WAS MADE BY TO FILE ON BEHALF OF (B)(4) AS A PRECAUTIONARY MEASURE. THE REGISTRATION NUMBER FOR (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 INSPECTION: VISUAL INSPECTION CONFIRMED A CRACK IN THE PACKAGING NEAR THE HANDLE OF THE PACKAGED DEVICE. THE OUTER CARTON WAS MEASURED AND ALL THICKNESS MEASUREMENTS WERE WITHIN SPECIFICATION. THE ROOT CAUSE IS BELIEVED TO BE A CHANGE THE PACKAGING PROCESS RELATED TO SITE AND REQUIRED ADDITIONAL SHIPMENT. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: TWO DIGITAL PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS THE LABELING OF DEVICE CONFIRMING THAT IT IS A CALIBER INFLATION DEVICE. THE SECOND PHOTO SHOWS A CRACK IN THE PACKAGING NEAR THE HANDLE OF THE DEVICE. BASED ON THE PROVIDED PHOTOS, THE INVESTIGATION CAN BE CONFIRMED FOR A PACKAGING ISSUE. CONCLUSION: A MANUFACTURING REVIEW WAS CONDUCTED AND THERE IS NO INDICATION THAT THE REPORTED EVENT IS MANUFACTURING RELATED. 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

    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 INSPECTION: VISUAL INSPECTION CONFIRMED A CRACK IN THE PACKAGING NEAR THE HANDLE OF THE PACKAGED DEVICE. THE OUTER CARTON WAS MEASURED AND ALL THICKNESS MEASUREMENTS WERE WITHIN SPECIFICATION. THE ROOT CAUSE IS BELIEVED TO BE A CHANGE THE PACKAGING PROCESS RELATED TO SITE AND REQUIRED ADDITIONAL SHIPMENT. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT PROVIDED; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: TWO DIGITAL PHOTOS WERE PROVIDED AND REVIEWED. THE FIRST PHOTO SHOWS THE LABELING OF DEVICE CONFIRMING THAT IT IS A CALIBER INFLATION DEVICE. THE SECOND PHOTO SHOWS A CRACK IN THE PACKAGING NEAR THE HANDLE OF THE DEVICE. BASED ON THE PROVIDED PHOTOS, THE INVESTIGATION CAN BE CONFIRMED FOR A PACKAGING ISSUE. CONCLUSION: A MANUFACTURING REVIEW WAS CONDUCTED AND THERE IS NO INDICATION THAT THE REPORTED EVENT IS MANUFACTURING RELATED. 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: 1. 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.

    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.

    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
    28949 CALIBER INFLATION DEVICE ANGIOGRAPHIC INJECTOR AND SYRINGE MAV PEROUSE MEDICAL 15085378 00801741090721

    Patients

    Seq Age Sex Outcome Treatment
    1