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 Obstruction of Flow (2423)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

It was reported that during a pre-use check, the gas sampling line was clogged or blocked.No patient involvement.

Manufacturer Narrative

Other, other text: b3: month and year of event have been provided, day is unknown.D4: expiration date, udi number and h4: manufacture date are unknown, no information is available based on reported lot number.G5: 510k is blank, device is exempt.One device was received.Visual inspection revealed a tear in the breathing circuit.A functional leak test was performed, and it was found occluded.The complaint was confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.A root cause has not been identified and the device has been sent to a second manufacturing site for a further detailed investigation.A supplemental report will be provided when further information becomes available.

Manufacturer Narrative

Email is: regulatory.Responses@icumed.Com.Secondary component investigation: one device sample was received without its original package.Four photos were included for evaluation; photos showed the complaint sample.The complaint was confirmed by visual inspection method, occlusion tube was found.The root cause was manufacturing caused during the bond luers operation.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 have been executed according, the manufacturer will continue monitoring this failure condition in this product for threshold or escalation.

• 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: 17899952
• MDR Text Key: 325259865
• Report Number: 3012307300-2023-09151
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• 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: 230614
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2023
• 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