MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA CIRCUIT; ANESTHESIA BREATHING CIRCUIT

Catalog Number CA32K0/4A2/000JP

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported that while in use with the product, leakage of air was observed.It was suspected that the connection part of the corrugated tube was loose.No patient injury.No additional information is available for this complaint.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms (b)(4).A sample was returned for evaluation; received inside of a plastic bag.The sample was visually inspected and there was damage in the circuit.Based on the visual inspection, the complaint is confirmed.During leak testing, it was noticed that the device was leaking.Additional testing was performed: such as evaluating the condition of the binders in the process and evaluating if the unit can be damaged if it is stuck.It was concluded that failure reported could not be reproduced in the manufacturing process according to the analyses.Root cause is unknown as the investigation did not reveal that the defect was caused during the manufacturing process.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.Updated d3.D4 (udi), g5 are unknown.

• Brand Name: PORTEX ANESTHESIA CIRCUIT
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• 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: 13565415
• MDR Text Key: 288656083
• Report Number: 3012307300-2022-03704
• Device Sequence Number: 1
• Product Code: OFP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CA32K0/4A2/000JP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2022
• 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