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

Catalog Number CA13E0/4K2/004JP

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 several places of the product was observed.No adverse patient effects were reported by the customer.It was reported that no further information is available.

Manufacturer Narrative

One used (pre-use check) device with original package was returned.A visual inspection noted a crack on the breathing circuit.As a result of magnifying and observing the crack, the recessed part of the breathing circuit was torn.A review of the kit process did not reveal any factors that could have caused the tear, as no tools were used.It is also unlikely that the damage was caused during transportation.A device history records (dhr) review found no discrepancies or anomalies during the manufacturing of the reported lot number.The device sample is being forwarded to a secondary manufacturing facility for further device analysis.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: the defective device was sent to the supplier for further investigation.One device and three photos were returned for investigation.Visual and function inspections were completed and a leaking defect was detected.The complaint is confirmed.The occurrence of this failure condition could be caused by overhandling during the manipulation of the component.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 GENERAL ANESTHESIA 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: 17039108
• MDR Text Key: 316320961
• Report Number: 3012307300-2023-05930
• 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: CA13E0/4K2/004JP
• Device Lot Number: 230118
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1