MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 197

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 20 jun 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported, the infant in the neonatal intensive care unit (nicu) was intubated with the 7fr in-line suction catheter, part of the adapter for the suction broke off and became stuck in the infant¿s endotracheal tube; it was removed with a hemostat clamp.There was no reported injury.Additional information received 02jun2022 reported that the catheter was in place between 12-24 hours [prior to the event].There was no reported injury.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 15 jul 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.

Manufacturer Narrative

The actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the neonatal ¿y¿ body small did not appear to have breakages around the connection/ bonding.The bonding area was place under uv light and illuminated.The ¿y¿ neonatal body was checked under magnification (30x) and did not exhibit any debris or jagged edges on the opening.The reported event could be confirmed as reported, the root cause has been traced to the manufacturing process.The device history record for lot 30162825 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 jan 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 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 CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER
• Type of Device: 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: 14749402
• MDR Text Key: 295499303
• Report Number: 8030647-2022-00159
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038938257
• UDI-Public: 00609038938257
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

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
• Device Operator: Health Professional
• Device Model Number: 197
• Device Catalogue Number: N/A
• Device Lot Number: 30162825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 06/23/2022; 01/05/2023
• Supplement Dates FDA Received: 07/15/2022; 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Sex: Male
• Patient Weight: 5 KG