MAUDE Adverse Event Report: NULL; AIRWAY CONNECTOR

Device Problem Misconnection (1399)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

No device was returned and no lot number was provided.No dhr review was able to be done.Root cause not able to be established.

Event Description

It was reported that the customer connected the product to the peep connection part of a disposable resuscitation bag during the use of the product.No patient injury.No additional information is available for this complaint.

• Type of Device: AIRWAY CONNECTOR
• Manufacturer (Section G): NULL
• MDR Report Key: 13122358
• MDR Text Key: 285369183
• Report Number: 3012307300-2021-13529
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/30/2021
• 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