MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CS NEO/PED, 6 FR, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	196
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via fda medwatch mw12180155 the following information: a fragment from an inline suction catheter was found in the left bronchus of a (b)(6)patient several days after initial intubation.Surgical intervention was needed to remove the foreign object confirmed to be a fragment from a kimberly clark kimvent closed suction system for neonatal/ pediatric, 6 fr "y" endotracheal tube adapter.1800 cxr chest x-ray showed possible foreign object, linear 1.7cm length, 3mm diameter.Imaging history reviewed by md and bedside nurse.Object was appreciated on previous cxr, but was difficult to see and was not identified on radiology report.Previous x-rays did not show anything that could be identified as a foreign object.Infant's bed was checked for external object and new imaging was obtained to confirm object was indeed inside of the patient's lung field.When confirmed that object was not external, (b)(6) was consulted and the decision was made to transport infant for further evaluation and intervention due to the availability of a transport ventilator that is available at pcmc.Follow up at pcmc and retrieval of the foreign body confirmed that it was a 6fr suction trachcare neonate 6fr 196.Additionally, the patient's status changed, a "code blue" was initiated and the patient expired.Additional information received 07-jan-2022 stated the patient had a major turn around and the medical chart noted the patient was (b)(6) and doing well.The patient did not expire.The user stated, "i¿m glad i was wrong in my initial report and was given inaccurate information when the patient has made a remarkable recovery." it was noted there was a crack in the tube and the health care professional(s) snipped just above that crack in the tube.Furthermore it was noted: on (b)(6) 2021, the patient was a (b)(6) newborn delivered after preterm labor (ptl).The patient was intubated at birth and managed on ventilator, and intubated with a 2.5 endotracheal tube (ett) with 6fr inline suction.On (b)(6) 2021, a significant ett leak was noted, the device was "swapped out" for a 3.0 ett, including larger 8fr, suction catheter.On (b)(6) 2021, a microbiology laboratory result confirmed klebsiella pneumonia, antibiotics were started.The patient had increasing secretions.On (b)(6) 2021, the patient continued to have more than normal secretions.Scheduled morning x-ray picked up opacity over left lung field, x-rays repeated to verify the reported foreign object in bronchus (rfob).On (b)(6) 20211, the patient underwent a procedure and a fragment of a 6fr inline suction catheter was removed.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation as the device was discarded after use.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 19-jan-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).

• Brand Name: BALLARD CS NEO/PED, 6 FR, Y-ADAPTER
• 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 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13315112
• Report Number: 8030647-2022-00002
• Device Sequence Number: 1463244
• Product Code: BSY
• UDI-Device Identifier: 00609038938240
• UDI-Public: 00609038938240
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 196
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 12/30/2021
• Initial Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 2.5 ENDOTRACHEAL TUBE; 3.0 ENDOTRACHEAL TUBE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 DA
• Patient Sex: Female