MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

Catalog Number C37101330-NLJ

Device Problem Gas/Air Leak (2946)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

It was reported that during the pre-use check, leakage of air from the connection part was observed.No patient injury or adverse effects reported.It was reported that no additional information is available for this complaint.

Manufacturer Narrative

B3: month and year of event have been provided, day is unknown.D4: udi section is unknown.G5: 510k is blank, device is exempt.Device evaluation: one device was received for investigation.Visual inspection confirmed the connector was damaged which could cause the leaking failure mode.Functional testing confirmed the leak.Based on the analysis conducted in the sample provided, leakage failure mode was confirmed for a connector damaged.Root cause of damage was not determined.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken at this time.

Manufacturer Narrative

Other text: new device evaluation findings: the root cause of the connector damage was attributed to manufacturing.This issue will continue to be monitored and further actions taken accordingly., corrected data: h6 - evaluation conclusion code: updated based on new findings.

Manufacturer Narrative

Upon further review of the device analysis, it was determined that the previous investigation information that was provided was incorrect.To clarify, the problem was present in the corrugated tube and not in the connector as was previously concluded and reported.Further evaluation of the photos provided by the manufacturing site confirmed the problem in the corrugated tube.This failure mode and root cause is currently being investigated.A retrospective review of a twelve (12) month period was made for complaints related to this issue and none were identified for the reported part and lot number.No non-conformances were identified in the device history record (dhr) review for this lot number., corrected data: h10 device evaluation findings, corrected.

• Brand Name: PORTEX ANESTHESIA CORRUGATED BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17397129
• MDR Text Key: 319847139
• Report Number: 3012307300-2023-07526
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101330-NLJ
• Device Lot Number: 4347787
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1