BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PUMP WITH SELECT-A-FLOW

    MDR report key: 17324402 · Received July 14, 2023

    Report

    Report Number
    2026095-2023-00077
    Event Type
    Injury
    Date Received
    July 14, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 13, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    MEB
    UDI-DI
    00193494134723
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: HEALTH EFFECT - CLINICAL CODE: APPROPRIATE TERM / CODE NOT AVAILABLE: METALLIC TASTE / SIDE EFFECT. H6: HEALTH EFFECT - IMPACT CODE: APPROPRIATE TERM / CODE NOT AVAILABLE: THERAPY / INFUSION PUMP DISCONTINUED. 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. ALL INFORMATION REASONABLY KNOWN AS OF 12 JUL 2023 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 REPORTED EVENT BUT IS RELAYING THE INFORMATION 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    FILL VOLUME: 550 ML, FLOW RATE: UNKNOWN, PROCEDURE: TOTAL KNEE ARTHROPLASTY, CATHPLACE: ADDUCTOR CANAL, INFUSION START TIME: ON (B)(6) 2023, INFUSION STOP TIME: ON (B)(6) 2023. IT WAS REPORTED, PATIENT RECEIVED AN ADDUCTOR CANAL CATHETER PRE-OPERATIVELY FOR POST-OPERATIVE PAIN CONTROL FOLLOWING TOTAL KNEE ARTHROPLASTY ON (B)(6) 2023. PATIENT DISCHARGED HOME ON (B)(6) 2023 WITH ON-Q PUMP AND ADDUCTOR CANAL CATHETER IN PLACE. WHEN THE PATIENT ARRIVED HOME, THE PATIENT COMPLAINED OF RINGING IN THE EARS, METALLIC TASTE IN THE MOUTH, AND FEELING LIGHTHEADED. THE PUMP AND CATHETER WERE REMOVED, AND THE SYMPTOMS RESOLVED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180493 ON-Q PUMP WITH SELECT-A-FLOW ELASTOMERIC - SAF MEB AVANOS MEDICAL INC. CB004 UNKNOWN 00193494134723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ON-Q T-BLOCK CATHETER TB100ST| ROPIVACAINE 0.25