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

Catalog Number C49101320J

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 breathing circuit was observed.No adverse patient effects were reported by the customer.It has been reported that no additional information is available for this event.

Manufacturer Narrative

Month and year of event have been provided, day is unknown.D4: udi section is blank, it is unavailable for this catalog number.G5: 510k 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 required.

Manufacturer Narrative

One device and two photos were returned for investigation.The returned sample was visually inspected and did not confirm any air leak defect.Then, the leak test was performed.The leaking defect was not detected in the leak test; complaint was not confirmed.No root cause could be determined since the complaint was not confirmed due sample provided does not shows failure mode reported.No corrective actions are required since the complaint was not confirmed.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX EXPANDABLE BREATHING CIRCUITS, PEDIATRIC
• 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: 16911989
• MDR Text Key: 315009581
• Report Number: 3012307300-2023-05563
• 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: 06/23/2023

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: C49101320J
• Device Lot Number: 4325661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1