MAUDE Adverse Event Report: CAREFUSION 303, INC. VERSASAFE SPLIT SEPTUM END CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Split (2537); Defective Device (2588)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

Rn noticed defective split septum connector on end of gray port of patient's picc line.Rn removed and replaced with a new split septum connector.

• Brand Name: VERSASAFE SPLIT SEPTUM END CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 5338197
• MDR Text Key: 34781827
• Report Number: 5338197
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 1000M
• Device Lot Number: 14075328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1