MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. PORTEX CATHETER MOUNT; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 100/590/000

Device Problems Air Leak (1008); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A report was received stating that the listed device was in use with a patient for an unknown amount of time when a tear was found in the catheter mount.There was no adverse effect to the patient reported.

Manufacturer Narrative

Manufacturer completed the entire form.Device evaluation: 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.

• Brand Name: PORTEX CATHETER MOUNT
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundry road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4268585
• MDR Text Key: 15314854
• Report Number: 2183502-2014-00826
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/590/000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/02/2014
• 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