MAUDE Adverse Event Report: SUNMED LLC SUNMED; E/T TUBE CUFFED 2.5MM 10FR

Model Number	1-7333-25
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint product was not returned for evaluation; however, the reporter provided photographic evidence.Analysis of the photo confirmed the reported complaint.The root cause could not be determined.There have been 2 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A review of complaint history identified two additional complaints involving the same part number and a similar failure mode within the preceding 24 months.No additional trends were identified; monitoring will continue for any emerging trends.The device history record for lot 2205010833 was reviewed, and confirmed that the product was manufactured according to specifications.All information reasonably known as of 10 apr 2026 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported that the 2.5 mm cuffed endotracheal tube (ett) did not allow passage of the 5/6 french suction catheter.On (b)(6), 2026, it was further noted that the event was associated with patient issues requiring extubation and reintubation.

• Brand Name: SUNMED
• Common Device Name: E/T TUBE CUFFED 2.5MM 10FR
• Manufacturer (Section D): SUNMED LLC; 2710 northridge dr. nw,; suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, 51917 0; CH 519170
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24847322
• Report Number: 1314417-2026-00021
• Device Sequence Number: 5664195
• Product Code: BTR
• UDI-Device Identifier: 10889483048108
• UDI-Public: (01)10889483048108(10)2205010833
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042683
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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: 1-7333-25
• Device Catalogue Number: 1-7333-25
• Device Lot Number: 2205010833
• 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: 02/04/2026
• Initial Report FDA Received Date: 04/11/2026
• 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
• Patient Sex: Unknown