MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD SAF-T-INTIMA IV CATHETER SYSTEM; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 383313

Device Problems Detachment of Device or Device Component (2907); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/14/2021

Event Type  malfunction  

Event Description

Iv placed by rn.After securing iv in place patient has bleeding on site.Upon checking, device failed.Tubing came apart from butterfly at connection by itself.

• Brand Name: BD SAF-T-INTIMA IV CATHETER SYSTEM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11482019
• MDR Text Key: 239748021
• Report Number: 11482019
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2021,03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383313
• Device Catalogue Number: 383313
• Device Lot Number: 0266500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2021
• Date Report to Manufacturer: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA