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

Catalog Number CA1300/4A2/000JP

Device Problem Gas/Air Leak (2946)

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number, expiration date, udi number and device manufacture date is unknown, no information has been provided to date.510k is blank, device is exempt.One device was received at the investigation site.Per visual inspection, the product component revealed a torn hole in it.Per functional testing, a leak test was performed and leakage from it was observed.The complaint was confirmed.A device history record (dhr) review could not be performed as the lot number was unknown.The device has been sent to the manufacturing facility for additional device analysis including a root cause.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 there was a leak.No patient injury or clinical affects was reported.

Manufacturer Narrative

Other text: d3, g1,2 email is: regulatory.Responses@icumed.Com.Secondary investigation/device analysis: per visual inspection, it was not possible to detect the perforation in the corrugated tube.Per functional leak testing, the result of the circuit tube test was rejected because there was an air leak.The complaint was confirmed.Other analysis, the manufacturing process was reviewed to try to identify somewhere that could result in the damage presented in the part returned, nothing was found on the workstation that could damage the connector during the review.Based on the analysis conducted with the device, the corrugated tube presents a perforation, which causes leakage, a root cause could not be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.A device history record (dhr) review could not be performed as the lot number was unknown.While a root cause was unable to be determined, the reported issue has been escalated and is currently being reviewed.

• 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: 18051335
• MDR Text Key: 327151952
• Report Number: 3012307300-2023-10150
• 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: 12/21/2023

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: CA1300/4A2/000JP
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/21/2023
• 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