MAUDE Adverse Event Report: CAREFUSION 303, INC. EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MXP5304-C

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2017

Event Type  malfunction  

Event Description

The carefusion 11" extension set (ref mxp5304-c) was not able to fully tighten to the 20ga angiocath pink hub, causing it to separate and leak during the contrast injection.

• Brand Name: EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6338781
• MDR Text Key: 67670398
• Report Number: 6338781
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2017,02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MXP5304-C
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1