MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE ORAL/NASAL CUFFED ENDOTRACHEAL TUBES; 3.0MM, HVLP,CUFFED,ET TUBE

Catalog Number	DYND43030
Medical Device Problem Codes	Difficult to Remove (1528); Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Swelling/ Edema (4577); Upper Respiratory Tract Injury (4599)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the facility that, "the neonate was intubated on (b)(6) 2026 with a 3.0-cuffed tube (medline brand).Could not be extubated in nicu on (b)(6) 2026 due to the fact that the ett got stuck in the larynx.Multiple attempts made by rt and providers.The cuff was deflated and the tape removed but ett seemed stuck.Determined airway was too swollen to extubate and ett had to be retaped and this ett is to remain in place until airway swelling subsides.Patient started on decadron.Ent consulted.This neonate underwent an ent airway evaluation and extubation in the or after removal of ett on (b)(6) 2026.It was found that the cuff of this ett was excessively large and rigid, which contributed to the problem.In addition, after full deflation, this cuff has large, hard, protruding edges that resemble the mercedes-benz logo in cross-section".
Additional Manufacturer Narrative
It was reported by the facility that, "the neonate was intubated on (b)(6) 2026 with a 3.0-cuffed tube (medline brand).Could not be extubated in nicu on (b)(6) 2026 due to the fact that the ett got stuck in the larynx.Multiple attempts made by rt and providers.The cuff was deflated and the tape removed but ett seemed stuck.Determined airway was too swollen to extubate and ett had to be retaped and this ett is to remain in place until airway swelling subsides.Patient started on decadron.Ent consulted.This neonate underwent an ent airway evaluation and extubation in the or after removal of ett on (b)(6) 2026.It was found that the cuff of this ett was excessively large and rigid, which contributed to the problem.In addition, after full deflation, this cuff has large, hard, protruding edges that resemble the mercedes-benz logo in cross-section".The facility stated, "patient had to return to or to get extubated under anesthesia and undergo bronchoscopy and laryngoscopy to evaluate cause of swelling and inability to remove tube on unit.After surgery, pt reintubated and transferred back to intensive care".It was reported that, "pt still hospitalized in nicu but on room air since on (b)(6) 2026, overall improving.Increasing her feeding and allowing recovery from vp shunt placement".No additional details are available related to the customer reported issue.It has been determined that the reported event caused or contributed to a death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: MEDLINE ORAL/NASAL CUFFED ENDOTRACHEAL TUBES
• Common Device Name: 3.0MM, HVLP,CUFFED,ET TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25679414
• Report Number: 1417592-2026-03779
• Device Sequence Number: 4657273
• Product Code: BTR
• UDI-Device Identifier: 10080196503773
• UDI-Public: 10080196503773
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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 Catalogue Number: DYND43030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other; Required Intervention
• Patient Age: 6 DA
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic
• Patient Race: White