MAUDE Adverse Event Report: NULL PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRC; ADULT EXPANDABLE BREATHING CIRCUIT

Catalog Number 54-05-112JP

Device Problem Disconnection (1171)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be evaluated as it was not returned.If the device is received in the future an evaluation will be performed.The reported event was unable to be confirmed or replicated.A cause of the reported event could not be determined at this time.

Event Description

It was reported that during the use of the product, the extension tube got detached from the pilot balloon.No patient injury.There is no additional information available for this complaint.

• Brand Name: PORTEX ADULT DISPOSABLE ANESTHESIA BREATHING CIRC
• Type of Device: ADULT EXPANDABLE BREATHING CIRCUIT
• Manufacturer (Section G): NULL
• MDR Report Key: 14653492
• MDR Text Key: 294590402
• Report Number: 3012307300-2022-11466
• Device Sequence Number: 1
• Product Code: CAI
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 54-05-112JP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2022
• 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
• Patient Sequence Number: 1