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

Catalog Number C1034J

Device Problem Leak/Splash (1354)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and 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.The udi is unknown, no product information has been provided to date.

Event Description

It was reported that during the pre-use air leak check, leakage was detected.No patient injury was reported.

Manufacturer Narrative

Event problem and evaluation codes: updated device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Three (3) pictures were attached, during the analysis conducted it could be observed in one sample a with focus on section with a tier damaged.Visual inspection: the returned sample was visually inspected.The sample present a tier damage (hole) in the circuit which confirm the failure mode reported.Functional test: sample was submitted to leak test inspection.The circuit was connected and failed the test, the failure mode is confirmed, as well the capacity to defect.It was tried to replicate the failure reported using the current tools of assembly process, following the process document.Failure reported could not be reproduced using the tools from assembly process.Additionally, leak test inspection is performed by production process to eventually detect this failure.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from molding and assembly process.Therefore the damage (hole) was after the product left the manufacturing facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.The cause of the reported problem could not be determined.No lot number was provided; therefore, dhr (device history review) could not be performed.No lot or serial numbers were communicated; d4: device expiration date and h4: device manufacturing date are not available.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• 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; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-15-26 fukushima,; minneapolis, MN 55442
• MDR Report Key: 15222059
• MDR Text Key: 302030501
• Report Number: 3012307300-2022-15340
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C1034J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1