BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14146339 · Received April 19, 2022

    Report

    Report Number
    2026095-2022-00037
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 11, 2022
    Report Date
    May 23, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSO
    UDI-DI
    00193494135355
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 18-APR-2022 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 19 MAY 2022 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CATHETER BROKE DURING USE. THE "PATIENT IS NOT SURE IF THE CATHETER WAS COMPLETELY REMOVED. SHE WASN¿T SURE IF SHE SAW THE BLACK TIP OF THE SILVER SOAKER CATHETER WHEN SHE REMOVED THE CATHETER." PER ADDITIONAL INFORMATION RECEIVED 22-APR-2022 THE PATIENT HAD UNDERWENT A TOTAL KNEE AMPUTATION (TKA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640690 ON-Q ANTIMICROBIAL EXPANSION KITS WITH SILVERSOAKER CATHETER 5 IN (12.5 CM) CATHETERS BSO AVANOS MEDICAL INC. PM020-A UNKNOWN 00193494135355

    Patients

    Seq Age Sex Outcome Treatment
    1 Female