MAUDE Adverse Event Report: SUNMED; AIRFLOW INFANT RESUSCITATOR WITH CORRUGATED TUBING, INTEGRATED MANOMETER, 2 FILT

Model Number AF3140MCPF

Device Problems Failure to Deliver (2338); Material Deformation (2976)

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

The tubing that was kinked, showed that the connector which connects the delivery tube was sealed off from the rest of the cannula tubing.This caused the infant to not receive ventilation.Although, there is a possibility of patient harm the infant did not show any adverse event from the lack of ventilation.Based on the reported information the criteria for reporting an adverse event have been met.

Event Description

Tubing was kinked and infant was not receiving ventilation.

Manufacturer Narrative

The tubing that was kinked, showed that the connector which connects the delivery tube was sealed off from the rest of the cannula tubing.This caused the infant to not receive ventilation.Although, there is a possibility of patient harm the infant did not show any adverse event from the lack of ventilation.Based on the reported information the criteria for reporting an adverse event have been met.Still pending the receival of the returned product for cc6742.We were unable to confirm this complaint since we did not have any in-house product to review nor did we have any pictures.We reviewed the batch record for this lot and there was nothing indicating that the tubing was received in as damaged.Based on how the product is packaged it is unlikely that the product was kicked during transit.However, if the product was packaged with the tubing on the side rather than beneath the bag, it could have become kinked and permanently deformed due to the high temperatures experienced during transit.I was unable to replicate the defect described without twisting the tubing in a way it was not intended to be twisted.This is part of our product design validation.The tubing used for the resus product line has 3 ribs on the inside of the tubing that are required for iso compliancy, see below.These ribs prevent the tubing from being completely closed and ensures that there is still o2 supply to the patient.We're going to close these complaints at this time pending product return.No cc or nc associated with this defect in 1 year.Ra: o2 occluded is listed as 6 6- major.

Event Description

Tubing was kinked and infant was not receiving ventilation.

• Brand Name: SUNMED
• Type of Device: AIRFLOW INFANT RESUSCITATOR WITH CORRUGATED TUBING, INTEGRATED MANOMETER, 2 FILT
• MDR Report Key: 12447209
• MDR Text Key: 274789927
• Report Number: 1314417-2021-00013
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AF3140MCPF
• Device Lot Number: 2101202
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other