MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	98383
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not available for return.A review of the device history record is in-progress.All information reasonably known as of 11 feb 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported, the child's closed suction system (csc) was changed every morning by ide.An attempt to flush saline through the orifice provided for this purpose on the closed system was made; however, the suction probe was blocked at the y [connector] and it was impossible to suction the child who desaturated.The decision to decode and to aspirate directly into the trachea with a standard suction tube was made.The csc was replaced and there were no additional problems after that.
Additional Manufacturer Narrative
Correction: g1.Additional information: h6.The actual complaint product was not available for return.Without a sample to perform functional evaluation or photographic /video evidence the root cause could not be determined.The device history record for lot 30322240 was reviewed and the product was produced according to product specifications all information reasonably known as of 30 may 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported; the child's closed suction system (csc) was changed every morning by ide.An attempt to flush saline through the orifice provided for this purpose on the closed system was made; however, the suction probe was blocked at the y [connector] and it was impossible to suction the child who desaturated.The decision to decode and to aspirate directly into the trachea with a standard suction tube was made.The csc was replaced and there were no additional problems after that.

• Brand Name: BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• 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, mx 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 21360545
• Report Number: 8030647-2025-00014
• Device Sequence Number: 8590440
• Product Code: BSY
• UDI-Device Identifier: 00609038983837
• UDI-Public: (01)00609038983837(10)30322240(240)120002753(17)290508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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 Model Number: 98383
• Device Catalogue Number: 195-5
• Device Lot Number: 30322240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2024
• 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
• Patient Sex: Unknown