MAUDE Adverse Event Report:; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Device Problem Device Damaged Prior to Use (2284)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

The elbow connector was returned and it was found to be damaged and cracked.The reported issue was able to be confirmed.It is probable that this event caused a crack due to a physical impact applied to the elbow connector.However, it was not possible to identify the time when the problem occurred, and it was not possible to identify the root cause of the problem.(b)(6).

Event Description

Information was received indicating that a smiths medical breathing circuit was found to be damaged at the elbow connector.This was found during a pre-use check and there were no reported adverse events.

• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• MDR Report Key: 12239995
• MDR Text Key: 263888996
• Report Number: 3012307300-2021-07734
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1