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

Catalog Number CA13E0/300/000JP

Device Problems Break (1069); Material Separation (1562)

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

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

H4: device manufacture date is unknown, no information has been provided to date.G5: 510k is blank, device is exempt.One device was received.Per visual inspection, the gas sampling port's connector was caught in the hme filter.No other anomaly was observed.A device history record (dhr) review could not be performed as the lot number was unknown.The returned device has been forwarded to the manufacturing site for a detailed investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during a pre-use check.The gas sampling line connection was damaged.No patient injury or clinical affects was reported.

Manufacturer Narrative

Other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com.H6 - evaluation codes updated.Device evaluation: the product was forwarded to the secondary investigation site.It was determined that part number was manufactured by a supplier.Complaint investigation was completed by the supplier.The supplier had never seen the item broken in that are previously.They determined the broken area "suffered a very big force.Which may have come from transportation, handling, or the opening method is twisted instead of pulling out".Cause of damage could not be fully established.

• 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: 18106950
• MDR Text Key: 329199934
• Report Number: 3012307300-2023-10420
• 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: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA13E0/300/000JP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2023
• 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