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

Device Problems Difficult or Delayed Positioning (1157); Leak/Splash (1354); Difficult to Advance (2920); Fail-Safe Problem (2936)

Patient Problems Exposure to Body Fluids (1745); Perforation of Vessels (2135)

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Adult ed- the following email was sent to ed pi: "10/10 do not recommend.Unable to thread appropriately, they keep blowing in ct, does not show flash, receiving increased hemolyzed labs since new iv catheter use, blood spatter when passive safety engages, passive safety means needle is only minimally covered -concern for patient or employee needle stick, harder to hold (especially for ultrasound guided ivs), unable to occlude.".

• 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: 16634746
• MDR Text Key: 312224188
• Report Number: 16634746
• 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