BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML

    MDR report key: 9782046 · Received March 3, 2020

    Report

    Report Number
    2026095-2020-00029
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 6, 2020
    Report Date
    May 29, 2020
    Manufacturer
    AVANOS MEDICAL - IRVINE
    Product Code
    BSO
    UDI-DI
    10680651137132
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 11-MAR-2020 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 · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 0002986472, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. ALL INFORMATION REASONABLY KNOWN AS OF 28-MAY-2020 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 10-MAR-2020 STATED MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT RECEIVED SURGERY UNDER SPINAL BLOCK ANESTHESIA TO RECOVER THE BROKEN TUBE ON (B)(6) 2020 AT 1905. THE TUBE WAS SUCCESSFULLY REMOVED. THE PATIENT WAS DISCHARGED ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 03-MAR-2020 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. 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 (B)(4).

    Description of Event or Problem · 1

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2020-00030 FOR THE SECOND EVENT. REFER TO 2026095-2020-00031 FOR THE THIRD EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: CAESARIAN SECTION (C-SECTION). CATHPLACE: UNKNOWN. IT WAS REPORTED THE CATHETER "SNAPPED OFF" IN THE PATIENT¿S C-SECTION WOUND. THE CATHETER STRETCHED AND SNAPPED. THE "SNAPPED OFF" PART WAS RETRIEVED. ADDITIONAL INFORMATION RECEIVED 10-FEB-2020 STATED THE REPORT ON THE INITIAL REMOVAL ATTEMPT NOTED RESISTANCE WAS EXPERIENCED WITH THE CONTINUED ATTEMPT TO REMOVE THE CATHETER. THE CATHETER STRETCHED AND THEN SNAPPED APART. THE PATIENT RETURNED TO THE OPERATING ROOM (OR) FOR REMOVAL OF THE CATHETER TIP FROM THE SUBCUTANEOUS SPACE. THERE WAS NO INJURY RELATED TO RETRIEVAL OF THE BROKEN CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241679 ON-Q PAIN RELIEF SYSTEM WITH DUAL SILVERSOAKER ANTIMICROBIAL CATHETERS, 270 ML CATHETERS BSO AVANOS MEDICAL - IRVINE PM015-A 0002986472 10680651137132

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR ANALGESIC