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

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Infiltration into Tissue (1931)

Event Date 02/18/2023

Event Type  malfunction  

Event Description

Patient with seemingly good vascularity noted to be stuck 5 times by 3 separate nurses to obtain iv access.Veins noted to infiltrate after stick or unable to advance needle/catheter.This nurse has noted an increase in iv misses or infiltrations with new iv catheters.

• 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: 16634673
• MDR Text Key: 312215612
• Report Number: 16634673
• 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