MAUDE Adverse Event Report: VYAIRE MEDICAL, INC CIRCUIT, NEONATAL 60" 10MM HOSE, .5L, LF; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number 1552017

Device Problem Occlusion Within Device (1423)

Patient Problem Hypoxia (1918)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

Unfortunately the actual circuit used during the case was disposed of.The only thing that was saved from the case was the small piece of plastic that blocked the filter.Attached to complaint are photos of the plastic piece.If a sample or any additional information becomes available a follow up emdr will be submitted.

Event Description

Customer reported "during resuscitation of patient, they went to use the anesthesia circuit.During use, they noticed that the patient was struggling for air so they quickly evaluated and found that there was a piece of plastic lodged between the face mask and filter.They quickly removed the plastic film and continued to resuscitate the patient"."the patient recovered and there was no harm".

Manufacturer Narrative

Device evaluation: the vyaire failure analysis lab received the photo of the plastic that was lodged between the face mask and the filter.The piece of plastic is not part of the circuit therefore, the reported issue is not able to be confirmed.If additional information becomes available then a supplemental report will be filed.

• Brand Name: CIRCUIT, NEONATAL 60" 10MM HOSE, .5L, LF
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 north riverwoods blvd; mettawa IL
• Manufacturer (Section G): VYAIRE MEDICAL, INC; cerrada via de la produccion; no. 85. parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 7319895
• MDR Text Key: 101702904
• Report Number: 8030673-2018-00415
• Device Sequence Number: 1
• Product Code: CAI
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1552017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention