MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY CATHENA, SAFETY IV CATHETER, 20 GAUGE, 1 INCH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 386862

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Iv catheter missing the end piece (white hub attached to needle-protects user and patient).

• Brand Name: CATHENA, SAFETY IV CATHETER, 20 GAUGE, 1 INCH
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 16350815
• MDR Text Key: 309270969
• Report Number: 16350815
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

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 Model Number: 386862
• Device Catalogue Number: 386862
• Device Lot Number: 2174759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1