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

Device Problems Inadequacy of Device Shape and/or Size (1583); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 304891983
• Report Number: 8030673-2022-00269
• Device Sequence Number: 1
• Product Code: NFB
• UDI-Device Identifier: 10190752117808
• UDI-Public: (01)10190752117808(10)0004208650
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1