MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Device Problems Difficult to Insert (1316); Mechanical Problem (1384); Positioning Problem (3009); Fail-Safe Did Not Operate (4046)

Patient Problems Failure of Implant (1924); Needle Stick/Puncture (2462)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Concern regarding iv catheters from rapid response: 1.The body of the iv is very short and that makes starting an iv on agitated and moving patients difficult.2.When pulling the needle out engaging the safety mechanism, it catches causing the catheter to slide out, losing the iv placement 3.No flash or late flash causing uncertainty in iv placement and iv removal.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 16634772
• MDR Text Key: 312224257
• Report Number: 16634772
• 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: 03/22/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Date Report to Manufacturer: 03/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1