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

Catalog Number C37101548

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the adult breathing circuit was leaking.Patient involvement unknown.

Manufacturer Narrative

Date of event and udi number is unknown, no information has been provided to date.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 additional reportable information becomes available.

Manufacturer Narrative

Device available for evaluation; h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.Thirteen devices were received in total.Eight were received without their original packaging, one of which was received without bag and five were received with their original packaging and completely sealed.During visual inspection, it was possible to detect one device with a broken/damaged tube, which caused the leaking failure mode; the rest of the twelve devices did not have any defects.A leak test was performed on the damaged device in which there was an air leak.The complaint was confirmed by visual inspection and functional testing.The root cause was damage caused by the improper handling of the product during its assembly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.All mitigations in place were verified and it was confirmed they have been executed accordingly, the manufacturer will continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX ANESTHESIA 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: 16914301
• MDR Text Key: 315037095
• Report Number: 3012307300-2023-05589
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: C37101548
• Device Lot Number: 4366662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1