MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE NASAL OXYGEN CANNULA CURVED, FLARED TIP, WITH 7 FEET (2.1 M) CRUSH RESIS; CANNULA, NASAL, OXYGEN

Model Number	CANNULA CRVD FLARE TIP W/7FT DISP 50/CS
Medical Device Problem Codes	Disconnection (1171); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer confirmed that the patient suffered transient severe hypoxia without aftereffects.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the connection at the beginning of the 001320 - airlife¿ nasal oxygen cannula curved, flared tip, with 7 feet (2.1 m) crush resistant tubing, over-the-ear style has changed.It is now stiffer/more rigid.As such, the goggle tip is not very compatible with the tip of the aquapak humidifier, causing frequent disconnections.The reported issue happened during patient use.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 and h10.Based on the investigation and the decontaminated physical samples received, we cannot confirm the reported defect since the samples were dimensionally inspected to measure the entrance of the green tips, and the samples came out acceptable in measuring within drawing specifications.In addition, the device history record was reviewed, and no issues were found during manufacturing.Therefore, the root cause was not confirmed.

• Brand Name: AIRLIFE NASAL OXYGEN CANNULA CURVED, FLARED TIP, WITH 7 FEET (2.1 M) CRUSH RESIS
• Common Device Name: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17331014
• Report Number: 8030673-2023-00335
• Device Sequence Number: 7404971
• Product Code: CAT
• UDI-Device Identifier: 10190752116160
• UDI-Public: (01)10190752116160(10)0004224228
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2023

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: CANNULA CRVD FLARE TIP W/7FT DISP 50/CS
• Device Catalogue Number: 001320
• Device Lot Number: 0004224228
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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