BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD MINI-BAL SAMPLING CATHETER 16 F

    MDR report key: 12509684 · Received September 21, 2021

    Report

    Report Number
    8030647-2021-00039
    Event Type
    Injury
    Date Received
    September 21, 2021
    Date of Event
    August 26, 2021
    Report Date
    January 14, 2022
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    OYI
    UDI-DI
    00609038111391
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. THE PRODUCT INVOLVED IN THE REPORT HAS BEEN RETURNED AND IS BEING PROCESSED FOR EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 21 SEP 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 INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, 30111533, IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE RETURNED PRODUCT WAS EVALUATED AND NO ISSUES WERE OBSERVED ON DEVICE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED FAILURE WAS NOT REPRODUCED IN LAB DURING SAMPLE EVALUATION. ALL INFORMATION REASONABLY KNOWN AS OF 27-OCT-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 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

    ALL INFORMATION REASONABLY KNOWN AS OF 13-JAN-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 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

    IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A MINI BAL [ALVEOLAR LAVAGE] PROCEDURE ON THE RIGHT LUNG WHEN THE PATIENT'S HEART RATE DROPPED AND VENTILATOR VOLUMES WOULD NOT RETURN TO PREPROCEDURAL VOLUMES. ET [ENDOTRACHEAL] TUBE HAD TO BE REMOVED FROM PATIENT'S AIRWAY. AT THAT TIME THE CSC [CLOSED SUCTION CATHETER] TIP WAS DETERMINED TO BE MISSING. IT WAS LATER LOCATED AND REMOVED. ACCORDING TO THE USER FACILITY, "FOLLOWED PROCEDURE GUIDELINES, 100% FIO2 [OXYGEN CONCENTRATION] SXN [SUCTION] PRIOR, TURN SUCTION PRESSURE DOWN TO 60. ADVANCED MINI BAL CATHETER INSIDE PT [PATIENT] ETT [ENDOTRACHEAL TUBE], TILL NUMBERS MATCHED. ADVANCING INNER CATHETER WITH INSPIRATION. DURING INSTILLATION 30ML OF SALINE WAS ADVANCED TO R [RIGHT] SIDE, TURNED STOPCOCK WITH NO RETURNED SPUTUM, EXTRA PRESSURE NOTED. PT STARTED TO BRADY TO 51. VOLUMES ON VENTILATOR NOT RETURNING. IMMEDIATELY WITHDREW ETT, ALLOWING PT TO RECOVER. DURING THIS TIME WITH CATHETER WITHDRAWN NOTED TIP OF CATHETER MISSING. FOUND MISSING CATHETER TIP PULLED BACK INTO CATHETER." ADDITIONAL INFORMATION RECEIVED 02-SEP-2021 INDICATED THE MINI BAL PROCEDURE WAS PERFORMED FOR BRONCHIAL SAMPLING. NO INTERVENTIONS WERE NEEDED; THE PATIENT HAD SAMPLING DONE DURING BEDSIDE TRACHEOTOMY. THE PATIENT WAS ALREADY INTUBATED AT THE TIME OF THE INCIDENT. THERE WERE NO SEQUELAE FROM THIS INCIDENT. THE CSC WAS IN PLACE "BRIEFLY, WITHIN MINUTES" WHEN THE INCIDENT OCCURRED AND IT HAD NOT BEEN ALTERED PRIOR TO THE REPORTED INCIDENT OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406196 BALLARD MINI-BAL SAMPLING CATHETER 16 F VAP AIRWAY DIAGNOSTICS BAL-CATH OYI AVANOS MEDICAL INC. 142 30111533 00609038111391

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Other