BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML, 2-14 ML/HR

    MDR report key: 8384681 · Received March 2, 2019

    Report

    Report Number
    2026095-2019-00036
    Event Type
    Malfunction
    Date Received
    March 2, 2019
    Date of Event
    February 10, 2019
    Report Date
    April 17, 2019
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    MEB
    UDI-DI
    30680651134722
    PMA / PMN Number
    K06353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 29-APR-2019 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. 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 AN AVANOS MEDICAL, INC. 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. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 01-MAR-2019 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 AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    FILL VOLUME: 500 ML, FLOW RATE: 8ML/HR, PROCEDURE: RIGHT KNEE ACL, CATHPLACE: FEMORAL NERVE BLOCK, (B)(6) 2019, DATE OF PROCEDURE: (B)(6) 2019. IT WAS REPORTED THE INFUSION PUMP WAS NOT WORKING IN THE TWO DAYS AFTER INSERTION, THEN IT INFUSED ALL OF ITS CONTENTS AT ONCE ON THE THIRD DAY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE ON-Q DEVICE RELEASED ALL OF ITS MEDICINE AT ONCE OVER THE WEEKEND, FROM FRIDAY THROUGH SUNDAY. THE PATIENT WAS IN A LOT OF PAIN, THE CATHETER WAS NOT DELIVERING MEDICATION. ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 STATED THE PATIENT TOLD THE NURSE THAT SHE WENT HOME WITH THE ON-Q THE SAME DAY EXPERIENCING SOME PAIN. ON (B)(6) 2019 THE PATIENT FELT THE ON-Q WAS "HARD" AND SHE STILL HAD A LOT OF PAIN, SO THE PHYSICIAN ORDERED MORE ORAL PAIN MEDICATION FOR THE PATIENT ON (B)(6) 2019. THE PATIENT COMPLAINED THAT THE ON-Q BALL WAS STILL "HARD" AND SHE WAS STILL IN A LOT OF PAIN AND DID NOT EXPERIENCE NUMBNESS ASSOCIATED WITH PAIN RELIEF. THE PATIENT TOOK A NAP AND NOTED THE PUMP WAS COMPLETELY FINISHED WHEN SHE AWOKE. THE DRESSING WAS WET BUT THE BEDDING WAS NOT WET NOR WERE HER CLOTHES WET. THE PATIENT DID NOT EXPERIENCE ANY LOCAL ANESTHETIC TOXICITY FOR THE INFUSION BUT STATED SHE EXPERIENCED A LOT OF PAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177506 ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW*, 400 ML, 2-14 ML/HR ELASTOMERIC - SAF MEB AVANOS MEDICAL - IRVINE CB004 UNKNOWN 30680651134722

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR PYANK CATHETER