MAUDE Adverse Event Report: AIRLIFE MICROCUFF; MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS/ORAL/NASAL MAGILL, MURPHY EYE/RADIOP

Model Number	35111
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they are noticing a marked increase in the incidence of pressure areas in patient's nares.
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 (b)(6) 2026 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.
Event or Problem Description
It was reported that they are noticing a marked increase in the incidence of pressure areas in patient's nares.
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 05 march 2026 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.Risk assessment: the ultimate risk is low, as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/caregiver: performed risk assessment with dhfe-05285 rev 8; the most closely associated risk is id hzd016-01 with a probability of harm occurring p=1 and severity s=3 which is low risk.The calculated p1 for part number 35111a based on complaints and sales in the previous 24 months is (b)(4) remote (2).The calculated p1 for part number 35112a based on complaints and sales in the previous 24 months is (b)(4) remote (2).The calculated p1 for part number 35113a based on complaints and sales in the previous 24 months is (b)(4) remote (2).Therefore, the probability of harm occurring (p) is the same as the rma and is determined to be low risk per ref-20001-c1 rev 2.2.Regulatory/ compliance: reviewed ref-20001-c1 rev 2, and there is low regulatory/ compliance risk.3.Brand recognition and customer impact: reviewed ref-20001-c1 rev 2, and there is low brand recognition/customer impact.Device history record (dhr) review: no issues found in the dhr.Based on the device history record (dhr) review there were no abnormal processing issues noted.All products/packaging were produced per the approved manufacturing procedures, specifications, and inspections.Complaint history review: the complaint history was reviewed in (b)(6) from reported dates 2/3/24 through 2/3/26, for part number 35111a and failure mode "a040607 - material too rigid or stiff".There were 0 other complaints reported for the same issue and part number, during the same timeframe.Sales = (b)(4) ea.Calculated occurrence (p1) = (1 / (b)(4)) x 100 = (b)(4).Occurrence ranking = 2.The complaint history was reviewed in (b)(6) from reported dates 2/3/24 through 2/3/26, for part number 35112a and failure mode "a040607 - material too rigid or stiff".There were 0 other complaints reported for the same issue and part number, during the same timeframe.Sales = (b)(4) ea.Calculated occurrence (p1) = (1 / (b)(4)) x 100 = (b)(4).Occurrence ranking = 2.The complaint history was reviewed in (b)(6) from reported dates 2/3/24 through 2/3/26, for part number 35113a and failure mode "a040607 - material too rigid or stiff".There were 0 other complaints reported for the same issue and part number, during the same timeframe.Sales = (b)(4) ea.Calculated occurrence (p1) = (1 / (b)(4)) x 100 = (b)(4).Occurrence ranking = 2.

• Brand Name: MICROCUFF
• Common Device Name: MICROCUFF ENDOTRACHEAL TUBE FOR PEDIATRICS/ORAL/NASAL MAGILL, MURPHY EYE/RADIOP
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): WELL LEAD MEDICAL CO; c-4 jinhu industrial estate; hualong; panyu, guangzhou 51143 4; JA 511434
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 24527659
• Report Number: 1314417-2026-00010
• Device Sequence Number: 8515310
• Product Code: BTR
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 35111
• Device Catalogue Number: 35111A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 35111A, 35112A, 35113A.; 35111A, 35112A, 35113A.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown