MAUDE Adverse Event Report: SUNMED SUNMED; E/T TUBE CUFFED 7.5MM 30FR

Model Number	1-7333-75
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the patient was placed on the ventilator after intubation, low volumes and high peak pressures was observed.An unsuccessful attempt was made to resolve the issue with medical intervention.However, the suction catheter would not pass, therefore bronchoscopy was attempted to observe the obstruction; the medical professional could not pass the bronchoscopy through the tube.The patient was extubated and reintubated with a different endotracheal tube (ett).It was additionally reported, the original ett was observed to be kinked (it was not kinked prior to intubation and was styleted with a rigid stylet).It was additionally reported, that the patient did not bite the tube on or after intubation; a mild temporary (unspecified) harm was sustained by patient.
Additional Manufacturer Narrative
H6: (appropriate term/code not available): 4581: low saturations and high volumes.The product involved in the report has not been returned for evaluation a review of the device history record is in-progress.All information reasonably known as of 24 jul 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 patient was placed on the ventilator after intubation, low volumes and high peak pressures was observed.An unsuccessful attempt was made to resolve the issue with medical intervention.However, the suction catheter would not pass, therefore bronchoscopy was attempted to observe the obstruction; the medical professional could not pass the bronchoscopy through the tube.The patient was extubated and reintubated with a different endotracheal tube (ett).It was additionally reported, the original ett was observed to be kinked (it was not kinked prior to intubation and was styled with a rigid stylet).It was additionally reported, that the patient did not bite the tube on or after intubation; a mild temporary (unspecified) harm was sustained by patient.
Additional Manufacturer Narrative
Additional information - investigation conclusion: h6.H6: (appropriate term/code not available): 4581: low saturations and high volumes.The actual complaint product was not available for return; evaluation performed on manufacturer retained samples; the devices performed within acceptable parameters when evaluated based on: kink/bend resistance.The device history record for lot 2401010197 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 sep 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 21 cfr 803, 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: SUNMED
• Common Device Name: E/T TUBE CUFFED 7.5MM 30FR
• Manufacturer (Section D): SUNMED; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22591472
• Report Number: 1314417-2025-00052
• Device Sequence Number: 9154449
• Product Code: BTR
• UDI-Device Identifier: 10889483001813
• UDI-Public: (01)10889483001813(10)2401010197
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 1-7333-75
• Device Lot Number: 2401010197
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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: Unknown