MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM FOR ADULTS; BALLARD CLOSED SUCTION CATHETER, T-PIECE

Model Number	93906
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(appropriate health impact term/code not available) e: trachea scrape.The product involved in the report is not available to be returned for evaluation.For the reported event of catheter curved and scraped against the tracheal wall of the patient the lot number of the device in question is unknown; however, the user had three (3) lot numbers on hand.A review of the device history record is in-progress.All information reasonably known as of 29 oct 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, during suctioning, the catheter curved and scraped against the tracheal wall of the patient and caused bleeding; no medical intervention was reported.
Event or Problem Description
It was reported, during suctioning, the catheter curved and scraped against the tracheal wall of the patient and caused bleeding; no medical intervention was reported.
Additional Manufacturer Narrative
Additional information/clarification: h11.Clarification: the user reportedly had 3 lots on hand; however, only one of the devices had blood on it.As no conclusive information was provided concerning the lot in question the lot number for the device in question is considered unknown.(appropriate health impact term/code not available) e: trachea scrape.The actual complaint product was not returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.In the absence of a photo or video, the complaint could not confirmed; without a sample to perform functional evaluation, a root cause could not be determined.For the reported event of catheter curved and scraped against the tracheal wall of the patient the lot number of the device in question is unknown; however, as the user had the following three (3) lot numbers on hand 1586754, 1590830, 1550959], a review of the device history record(s) was performed.The device history record for [1586754, 1590830, 1550959] were reviewed and the product(s) were all produced according to product specifications.All information reasonably known as of 04 dec 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.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS
• Common Device Name: BALLARD CLOSED SUCTION CATHETER, T-PIECE
• 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
• MDR Report Key: 23420567
• Report Number: 8030647-2025-00111
• Device Sequence Number: 9863388
• Product Code: BSY
• UDI-Device Identifier: 00609038939063
• UDI-Public: (01)00609038939063
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 93906
• Device Catalogue Number: 2205
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male