MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL PORTEX CATHETER MOUNT WITH DOUBLE SWIVEL CONNECTOR

Catalog Number 100/594/000

Device Problems Air Leak (1008); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/14/2015

Event Type  malfunction  

Event Description

A report was received stating that the listed device was in use with a patient when the clinician re-positioned the patient.The catheter mount disconnected from the swivel connector which caused a leak in the listed device.There was no adverse effect to the patient reported.

Manufacturer Narrative

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 WITH DOUBLE SWIVEL CONNECTOR
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL; 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: 4690476
• MDR Text Key: 5638771
• Report Number: 2183502-2015-00220
• Device Sequence Number: 1
• Product Code: BZA
• 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,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/594/000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2015
• Distributor Facility Aware Date: 03/14/2015
• Event Location: Hospital
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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