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

Catalog Number CA25K0/400/000JP

Device Problem Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2023

Event Type  malfunction  

Event Description

It was reported that during a pre-test a leak occurs.Patient involvement unknown.

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided; day is unknown.D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.D4.Udi number is unknown, no information has been provided to date.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 additional reportable information becomes available.

Manufacturer Narrative

One device was returned.Visual inspection revealed no abnormalities such as damage related to the reported event.A leak test was performed and leakage from the breathing circuit was confirmed.The complaint was confirmed.No other anomaly was observed.A root cause was not established however it was believed the leakage occurred before being supplied to the distribution facility.A device history record (dhr) review found no discrepancies or anomalies in the reported lot number.The device was sent to the manufacturing site for further device analysis.

Manufacturer Narrative

H6 codes updated.Device evaluation.One device was returned for investigation without original packaging.Device was visually inspected where no apparent defects were found.Functional testing was done where no device issue was found, customer complaint was not confirmed.Device history review of the reported lot number showed no non-conformities of the reported lot number during the manufacturing process.

• 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: 17325078
• MDR Text Key: 319522944
• Report Number: 3012307300-2023-07207
• 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,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA25K0/400/000JP
• Device Lot Number: 230125
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/06/2023
• 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
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1