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

Catalog Number C45101340-NLJ

Device Problem Gas/Air Leak (2946)

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

Event Date 06/01/2023

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Other text: b3: month and year of event have been provided, day is unknown.D4: udi section is unknown, no information is available.G5: 510k number is blank, device is exempt.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

One photo of the device and one sample of the device were received for investigation.During visual inspection, no damage or anomalies were observed on the device.The device was functionally tested, and no leakage was observed.A review of the manufacturing device history records (dhr) shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with the reported lot of products.Based on the available information, the investigation could not confirm the reported complaint or assign a root cause.No actions have been assigned at this time.

• Brand Name: PORTEX EXPANDABLE BREATHING CIRCUITS
• 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: 17299611
• MDR Text Key: 318873412
• Report Number: 3012307300-2023-07095
• 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
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C45101340-NLJ
• Device Lot Number: 4364562
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1