MAUDE Adverse Event Report: NULL ADULT ANESTHESIA BREATHING CIRCUITS; ANESTHESIOLOGY

Catalog Number CA1300/0K2/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that during pre-test, an air leak alarm went off indicating leakage of air from the product.No patient injury was reported.No additional information is available for this complaint.

Manufacturer Narrative

One device was returned for investigation.A leak test was done and it was confirmed that the internal pressure did not rise and did not conform to the standards of the manufacturing site.When observing the corrugated tube, a tear was found at a distance of 50 cm from the tip of the 22 mm connector.The supplier was notified of this and sent the device.Updates will be provided as information comes.Protocol # and device manufacture date unavailable.

Manufacturer Narrative

H6: health impact and evaluation codes: updated no lot number was provided; therefore, device history record review could not be performed.A product sample and two (2) pictures were received for evaluation.Visual inspection found a tier damage due embedded resin in the circuit; thus, failure mode is confirmed.Per trend review as leakage failure an escalation was performed to investigate this failure and determine the root cause through an internal capa.The principal cause defined by the team is the screw and barrel wear on flights, condition that affect directly to the internal plastination process due worn flights on screw.Current capa status ? implementation results.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: ADULT ANESTHESIA BREATHING CIRCUITS
• Type of Device: ANESTHESIOLOGY
• Manufacturer (Section G): NULL
• MDR Report Key: 15551533
• MDR Text Key: 306884119
• Report Number: 3012307300-2022-21925
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2023

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
• Device Catalogue Number: CA1300/0K2/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1