BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD

    MDR report key: 6984443 · Received October 27, 2017

    Report

    Report Number
    8030647-2017-00131
    Event Type
    Malfunction
    Date Received
    October 27, 2017
    Date of Event
    September 28, 2017
    Report Date
    December 18, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR M7172L605 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 27-OCT-17 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THERE WAS NO VISIBLE DAMAGE OR DEFECT ON THE SLEEVE OR MANIFOLD. THE PEEP SEAL IS PRESENT AND INTACT. THE TUBING WAS FULLY RETRACTED WITH PERCEIVED NORMAL FORCE. AT THE END OF RETRACTION, A PERCEIVED "SNAP" WAS FELT. UPON EXAMINATION IT WAS OBSERVED THAT A COMPRESSION RING HAD BEEN CREATED ON THE OUTER WALL OF TUBING, CAUSED FROM THE ID OF THE PEEP SEAL. WHEN RETRACTED TO THIS POSITION, THE PROXIMAL SKIVE WAS CENTERED ON THE PEEP SEAL. IN THIS POSITION, NO SLACK WAS OBSERVED IN THE SLEEVE. THE BLACK MARKER WAS POSITIONED APPROXIMATELY 1.5CM ABOVE THE SLEEVE COLLAR. THE TUBING WAS MANUALLY REPOSITIONED WITH THE BLACK MARKER JUST ABOVE THE SLEEVE COLLAR. IN THIS POSITION, VISIBLE SLACK WAS OBSERVED IN THE SLEEVE. THE MANUFACTURING PROCESS WAS REVIEWED, AND IT WAS DETERMINED THAT A POTENTIAL ROOT CAUSE OF THE REPORTED EVENT IS INCORRECT ASSEMBLY OF THE CATHETER IN THE SEAL CARTRIDGE. ALL INFORMATION REASONABLY KNOWN AS OF 20 DEC 2017 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS SLEEVE INFLATION UPON CONNECTION OF THE SUCTION CATHETER. THE SLEEVE DID NOT DEFLATED, AND WAS THEREFORE REMOVED AND REPLACED WITH ANOTHER SUCTION CATHETER. THE INCIDENT OCCURRED UPON CONNECTION TO THE PATIENT. THERE WAS NO INJURY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762901 CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 991098310 M7172L605

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR