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

Catalog Number C37101368-NLJ

Device Problems Air Leak (1008); Tears, rips, holes in device, device material (1628)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2014

Event Type  malfunction  

Event Description

A report was received that alleges the device was found to leaking after an unknown in use.The report stated that a hole was found in the corrugated tubing.There were no adverse effects to the patient.

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Explanation of method code "other": a sample device was returned and is currently in transit to the investigation site.

• Brand Name: PORTEX ANESTHESIA BREATHING CIRCUIT
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; hythe, kent ; UK
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; boundary road; hythe,kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3786367
• MDR Text Key: 21997251
• Report Number: 2183502-2014-00159
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C37101368-NLJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2014
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1