MAUDE Adverse Event Report: AIRLIFE AIRLIFE; PREFILL NEBULIZER KIT

Model Number	CK0010
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Insufficient Device Problem Information (3190); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the catheter has gotten loose from the verso adapter.When trying to put it back she notice that the tip of the catheter has broken loose and are stuck inside the verso adapter".
Additional Manufacturer Narrative
H^: catheter.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 26 nov 2024 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 (b)(4).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 (b)(4).(b)(4).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 (b)(4) 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 (b)(4).Product is defective or causes serious injury.
Event or Problem Description
It was reported that "the catheter has gotten loose from the verso adapter.When trying to put it back she notice that the tip of the catheter has broken loose and are stuck inside the verso adapter".
Additional Manufacturer Narrative
H: catheter 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 26 nov 2024 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 sunmed 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 sunmed holdings llc.Sunmed 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 sunmed holdings 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 sunmed holdings llc.Product is defective or causes serious injury.The complaint of nurse notice that the catheter has gotten loose from the verso adapter.When trying to put it back she notice that the tip of the catheter has broken loose and are stuck inside the verso adapter regarding product csc112 was not confirmed.The possible causes for failure could be external force by user's equipment or improper connection of catheter and adapter.A risk assessment was performed, and the ultimate risk was determined to be middle which required capa option and reporting to the carb review board for evaluation (the complaint have been entered into elg-20026-c1 as (b)(4)).There have bene 0 other complaints regarding the same part and a similar issue within the 24 months proceeding the reporting of this issue.Complaint will continue to be monitored for possible trend.
Additional Manufacturer Narrative
Upon further review the report needs to be updated to reflect the year the report was received (2025); a new initial report will be submitted under new fda mw report mw 8030673-2025-00028; no further information concerning this reported event will be submitted in fda mw report mw: 8030673-2024-01035.All information reasonably known as of 01 aug 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.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 8030673-2024-01036 for the second report.It was reported after the respiratory therapist (rt) established the unit on the patient in the intensive care unit (icu), the nurse noticed the patient's oxygen (o2) saturation dropped.The rt was called and the device was removed as the patient was struggling to breathe and their saturations were so low they had to be intubated.It was additionally reported, the patient experienced an unspecified life-threatening injury; no additional information was provided.

• Brand Name: AIRLIFE
• Common Device Name: PREFILL NEBULIZER KIT
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI 60045
• Manufacturer (Section G): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mx 21397 ; MX 21397
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 20793132
• Report Number: 8030673-2024-01035
• Device Sequence Number: 20785999
• Product Code: OGG
• UDI-Device Identifier: 10190752158450
• UDI-Public: (01)10190752158450(10)004298169
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2025

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: CK0010
• Device Catalogue Number: CK0010
• Device Lot Number: 004298169
• 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: 10/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024; 07/02/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/10/2025; 08/03/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown