BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM)

    MDR report key: 11821902 · Received May 13, 2021

    Report

    Report Number
    2026095-2021-00057
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 21, 2021
    Report Date
    July 13, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSO
    UDI-DI
    00193494135355
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4, LOT NUMBER PROVIDED BY THE CUSTOMER WAS NOT A VALID LOT NUMBER. LOT NUMBER CHANGED TO UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS A VALID LOT NUMBER WAS NOT PROVIDED. ONE USED CATHETER WAS RETURNED FOR EVALUATION. ONLY THE PROXIMAL PORTION OF THE CATHETER WITH A BLUE FEMALE LUER HUB ATTACHED WAS RETURNED. THE MAIN LENGTH OF THE CATHETER WAS NOT RETURNED. THE BREAK OCCURRED AT APPROXIMATELY 5.2CM FROM THE PROXIMAL END, THEREFORE THE COMPLAINT IS CONFIRMED AS REPORTED. HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 13 JUL 2021 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 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 PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2021 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 COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE CATHETERS PLACED IN THE PATIENT AFTER A TOTAL KNEE REPLACEMENT SURGERY BROKE. "THE PATIENT WAS STAYING OVERNIGHT AFTER THE PROCEDURE AND THIS INCIDENT HAPPENED SOMETIME DURING THE NIGHT. THE CATHETER WAS SECURED WITH SKIN GLUE, STERI STRIPS AND TEGADERM AFTER BEING PLACED. EVEN IF THE PATIENT ROLLED OVER WHILE SLEEPING, THIS WOULD HAVE TAKEN SOME AMOUNT OF FORCE TO BREAK WHERE IT DID. THE PAIN BALL WAS OUT OF THE WAY OF THE PATIENTS LEG AND ON THE BED NEXT TO THEM." PER ADDITIONAL INFORMATION RECEIVED VIA THE SALES REPRESENTATIVE, THE CATHETER PIECE WAS REMOVED FROM THE PATIENT. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715816 ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM) ON-Q CATHETERS-SILVERSOAKER BSO AVANOS MEDICAL INC. PM020-A UNKNOWN 00193494135355

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR