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

Device Problems Leak/Splash (1354); Difficult to Advance (2920); Fail-Safe Problem (2936); Human-Device Interface Problem (2949)

Patient Problems Perforation of Vessels (2135); Needle Stick/Puncture (2462)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Adult ed- the following email was sent to ed pi from staff member: "they are horrible for ejs (external jugular vein cannulation).Very few successful ejs with the new cath.Blood spatter when retracting the needle from the cath with the safety lock.Feels very unsafe in your hand having an exposed needle on exit.They are also blowing while performing iv contrast injection.Really difficult to hold in hand when starting iv.".

• 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: 16634773
• MDR Text Key: 312224220
• Report Number: 16634773
• 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