MAUDE Adverse Event Report: AIRLIFE AIR LIFE; ENDOTRACHEAL TUBE, SUB-GLOTTIC SUCTION, PARKER FLEX-TIP, HV / LP POLYURETHANE

Model Number	I-PFTVPU-80
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, on (b)(6) 2025 in the morning, intubation of the patient was performed.Suctioning was performed every hour after the start of use.On (b)(6) 2025 at 10:00 a.M., suctioning was performed due to the patient choking; a cuff leak occurred after suctioning.The tidal volume and spo2 of the patient dropped.The doctor reintubated the patient with a new tube.It was additionally reported, the cuff has continually inflated for over 100 hours when the suction end of the tube was capped.
Additional Manufacturer Narrative
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 20 jun 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, on (b)(6) 025 in the morning, intubation of the patient was performed.Suctioning was performed every hour after the start of use.On (b)(6) 2025 at 10:00 a.M., suctioning was performed due to the patient choking; a cuff leak occurred after suctioning.The tidal volume and spo2 of the patient dropped.The doctor reintubated the patient with a new tube.It was additionally reported; the cuff has continually inflated for over 100 hours when the suction end of the tube was capped.
Additional Manufacturer Narrative
Correction: h6.The product involved in the report was not returned for evaluation, but the reporter did provide photographic images which confirmed the event as report; however, the root cause could not be determined.The device history record for lot 2402tvu0579m was reviewed and the product was produced according to product specifications.All information reasonably known as of 08 july 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: AIR LIFE
• Common Device Name: ENDOTRACHEAL TUBE, SUB-GLOTTIC SUCTION, PARKER FLEX-TIP, HV / LP POLYURETHANE
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): AIR LIFE; 30 spur dr; el paso TX 79906
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22302957
• Report Number: 3004748541-2025-00014
• Device Sequence Number: 20889549
• Product Code: BTR
• UDI-Device Identifier: 10749065101808
• UDI-Public: (01)10749065101808(10)2402TVU0579M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNKNOWN
• 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): 07/08/2025

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: I-PFTVPU-80
• Device Catalogue Number: I-PFTVPU-80
• Device Lot Number: 2402TVU0579M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/08/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown