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

Lot Number 4153196

Device Problem Material Integrity Problem (2978)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to smiths medical.A leak test inspection was performed on the returned device; the device presented leakage.Based on the visual inspection, the reported nonconformance is confirmed.The sample presented leakage due embedded resin (damage) in the circuit.This issue reported is aligned per investigation opened under ncr (b)(4) on (b)(6) 2021.Per trend review as leakage failure an escalation was performed to investigate this failure and determine the root cause.Escalation was initiated on (b)(6) 2021 under ncr (b)(4).Corrective actions will be addressed and implemented trough ncr (b)(4).

Event Description

It was reported that during the pre-use check, a pinhole in the breathing circuit was found.No patient injury.No patient injury was reported.No additional information is available for this complaint.Please put a product photo(s) in the investigation report.If a product photo(s) provided by smj are uploaded to this complaint, please post it/them on the investigation report wherever possible.No patient injury was reported.

Manufacturer Narrative

Corrected b1, corrected data: corrected b1: product problem.

• 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 13480254
• MDR Text Key: 287807823
• Report Number: 3012307300-2022-02872
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4153196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1