MAUDE Adverse Event Report: BD BD NEXIVA; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM

Model Number 20 GAUGE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 01/13/2016

Event Type  malfunction  

Event Description

Iv catheter hep-locked in patient's arm.Nurse walked into patient's room and found iv catheter to still be in the patients arm, taped to arm, but the pink double y hub section was detached and laying in the bed.Nurse feels strongly that pt.Did not pull at iv because iv was not pulled out of his arm.She feels if he would have pulled that hard it would have come out.

• Brand Name: BD NEXIVA
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): BD; 5859 farinon drive suite 200; san antonio TX 78249
• MDR Report Key: 5392619
• MDR Text Key: 36894527
• Report Number: 5392619
• 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: Patient
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 20 GAUGE
• Device Catalogue Number: 383536
• 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: 01/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2016
• 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
• Treatment: NO OTHER THERAPIES