MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ PEDIATRIC CUSHION NASAL CANNULA WITH 7 FOOT (2.1 M) CRUSH-RESISTANT OXY; NASAL OXYGEN CANNULA, BASIC

Model Number	CANNULA SOFT PED W/U-CON 7FT TB 50/CS
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the cannula soft ped w/u-con 7ft tb 50/cs does not reach up the customer's nose, and the opening is narrow and too short.The customer was not able to get any oxygen through the cannula.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE¿ PEDIATRIC CUSHION NASAL CANNULA WITH 7 FOOT (2.1 M) CRUSH-RESISTANT OXY
• Common Device Name: NASAL OXYGEN CANNULA, BASIC
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15452336
• Report Number: 8030673-2022-00269
• Device Sequence Number: 20596261
• Product Code: NFB
• UDI-Device Identifier: 10190752117808
• UDI-Public: (01)10190752117808(10)0004208650
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

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: CANNULA SOFT PED W/U-CON 7FT TB 50/CS
• Device Catalogue Number: SFT2692
• Device Lot Number: 0004208650
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/19/2022
• 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
• Patient Sex: Unknown