MAUDE Adverse Event Report: AIRLIFE AIRLIFE; TRI-FLO SUCTION CATH-N-GLOVE KIT

Model Number	4698T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.The udi-di-pi is not available as no stock/product code or lot number was provided.All information reasonably known as of 16 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.
Event or Problem Description
It was reported that the patient's nurse was suctioning the patient when the catheter broke and became lodged in the patient's trachea.The patient's mother called 911, and the patient was transported to the emergency department/icu, where a procedure was performed to remove the catheter.The patient was admitted for six days and discharged on (b)(6) 2025.The patient's current condition was not reported.

• Brand Name: AIRLIFE
• Common Device Name: TRI-FLO SUCTION CATH-N-GLOVE KIT
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr. nw, suite; grand rapids MI 49544
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85 parque industrial; baja california, mexicali 21397 ; MX 21397
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 23824402
• Report Number: 8030647-2025-00140
• Device Sequence Number: 9287906
• Product Code: OFO
• UDI-Device Identifier: 10889483584187
• UDI-Public: (01)10889483584187
• 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: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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: 4698T
• Device Catalogue Number: 4698T
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 07/04/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 07/20/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Unknown