MAUDE Adverse Event Report: Not an Air Life Branded Device Not an Air Life Branded Device; Closed Suction Catheter, Y-Adapter, Neonatal/Pediatric

Model Number	Unknown
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	07/31/2026
Type of Reportable Event	Malfunction

• Brand Name: Not an Air Life Branded Device
• Common Device Name: Closed Suction Catheter, Y-Adapter, Neonatal/Pediatric
• Manufacturer (Section D): Not an Air Life Branded Device; not provided; not provided GA
• Manufacturer (Section G): Not an Air Life Branded Device; not provided; not provided; not provided, mx 84160 ; MX 84160
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 50464227
• Report Number: 8030647-2026-00061
• Device Sequence Number: 9811335
• Product Code: BSY
• UDI-Device Identifier: 10889483563694
• UDI-Public: (01)10889483563694(10)KS2408035
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: Unknown
• Device Catalogue Number: Unknown
• Device Lot Number: KS2408035
• 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: 07/31/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown