MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. CLOSED IV CATHETER SYSTEM DUAL PORT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Catalog Number 383536

Device Problems Difficult to Remove (1528); Defective Component (2292)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/09/2015

Event Type  malfunction  

Event Description

Rn on duty inserted a nexiva iv catheter in a patient; could not withdraw the needle from the iv/catheter, blood immediately started to come from around the iv at the site.Nurse pulled the catheter and found what appeared to be a defective iv.

• Brand Name: CLOSED IV CATHETER SYSTEM DUAL PORT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 5331645
• MDR Text Key: 34544073
• Report Number: 5331645
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 12/16/2015,12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 383536
• Device Lot Number: 5240856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR