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

Catalog Number CA25B0/400/000JP

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

It was reported that there was a pinhole in the anesthesia circuit.When the anesthesia circuit was connected and a leak check was performed, a pinhole was found in the anesthesia circuit.No injury or adverse effects reported.

Manufacturer Narrative

Other, other text: d4: expiration date, udi section, and h4: manufacture date are unknown, no information available.G5: 510k is blank, device is exempt.Device evaluation: one device was returned for investigation.Visual observation of the above components confirmed a pinhole in the breathing circuit.No other anomaly was found.The complaint was confirmed during functional testing.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.It is considered that leakage occurred before being supplied to to the manufacturing facility.The sample will be sent to the manufacturing site for a detailed investigation.

Manufacturer Narrative

Other text: d10, h3, and h6 - evaluation codes: device evaluation: one device was returned for investigation.Visual inspection found embedded resin was detected in the device.Functional testing found the leak test was not acceptable; complaint was confirmed.Root cause was attributed to the embedded resin which occurred during the extrusion process.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.This issue will continue to be monitored and further actions taken accordingly.

• 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: 17378851
• MDR Text Key: 319589694
• Report Number: 3012307300-2023-07506
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA25B0/400/000JP
• Device Lot Number: 230522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 08/20/2023
• Supplement Dates FDA Received: 08/23/2023
• 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