MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE¿ U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1 M) CRUSH-RESISTANT OXYGEN TUBING

Model Number	001350
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: loose connection between the tubing and the equipment; it literally falls off with the slightest bit of motion the material feels stiff.No reported injury.While no harm or injury was reported, any component that is part of the vent circuit (flex connector, double swivel elbow, y-adapter, t-piece, ett adapter, etc.) breaks, cracks, or leaks after the vent circuit has been established on the patient could cause a delay in care and or lead to a serious injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress all information reasonably known as of 18 july 2025 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 complaint (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 a airlife product is defective or causes serious injury.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress all information reasonably known as of 18 july 2025 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 complaint - (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 the complaint reported, "the connection between the tubing and our equipment disconnects with the slightest movement due to the stiffness of the connection material." the issue occurred during patient use; however, no patient was affected or harmed.Since no sample, photos, or video were provided, the complaint could not be confirmed; therefore, no root cause was determined.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board this is the third complaint reported for part number 001350, " disconnection/connection issue(s) " failure mode.There was one other complaint reported for part number 001350 during the same timeframe.A resolution letter was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.
Event or Problem Description
It was reported: loose connection between the tubing and the equipment; it literally falls off with the slightest bit of motion the material feels stiff.No reported injury.While no harm or injury was reported, any component that is part of the vent circuit (flex connector, double swivel elbow, y-adapter, t-piece, ett adapter, etc.) breaks, cracks, or leaks after the vent circuit has been established on the patient could cause a delay in care and or lead to a serious injury.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1 M) CRUSH-RESISTANT OXYGEN TUBING
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): AIRLIFE; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 22549423
• Report Number: 1314417-2025-00050
• Device Sequence Number: 18451000
• Product Code: CAT
• UDI-Device Identifier: 10190752116252
• UDI-Public: (01)10190752116252
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 001350
• Device Catalogue Number: 001350
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown