MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CS NEO/PED, 8 FR, ELBOW; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	208
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	03/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 20-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).
Event or Problem Description
It was reported the etco2 [end-tidal carbon dioxide] was reading low as well as exhaled volume.The patient's breath sounds were clear and bilaterally with no audible leak heard.The patent's trach cuff was deflated and reinflated.Display on etco2 showed a much lower rr [respiratory rate] than the patient's actual rr so all end tidal disposable equipment was replaced, and a new module was used with no change in etco2 or rr reading.No audible leak was noted, and the in-line suction catheter was able to pass and functioned.The patient was much less arousable than usual.An i-stat [blood analysis test] was performed using venous blood showing normal values.The ventilator was then changed to a v500 machine and problem of high leak persisted.The tracheostomy was then changed to rule out airway dislodgement to no avail.The only part of the patient ventilator circuit that was not replaced yet was the in-line suction catheter and after doing that it was noticed that the suction button did not fully spring back to completely off leaving a continuous suction to the airway.
Additional Manufacturer Narrative
The device history record for the reported lot number, 30150009, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 02-feb-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 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.

• Brand Name: BALLARD CS NEO/PED, 8 FR, ELBOW
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 14173041
• Report Number: 8030647-2022-00129
• Device Sequence Number: 20086335
• Product Code: BSY
• UDI-Device Identifier: 00609038938332
• UDI-Public: 00609038938332
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2026
• Device Model Number: 208
• Device Catalogue Number: N/A
• Device Lot Number: 30150009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: V500 VENTILATOR MACHINE.
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 14 KG