MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA DIFFUSICS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 383592

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2018

Event Type  malfunction  

Event Description

Diffusics catheter failure.Nurse placed d iv prior to procedure, just secured device attempted to attach 10 cc syringe to flush device and tubing broke off from the device.Nurse immediately pulled the catheter.No harm to patient.

• Brand Name: BD NEXIVA DIFFUSICS
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 9450 south state street; sandy UT 84070
• MDR Report Key: 7595612
• MDR Text Key: 110874839
• Report Number: 7595612
• 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: 06/05/2018,06/08/2018

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 Expiration Date: 11/30/2020
• Device Model Number: 383592
• Device Catalogue Number: NOT AVAILABLE
• Device Lot Number: 7326874
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1