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

Model Number 4252520-02

Device Problems Defective Device (2588); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

Started peripheral iv without incident.Tried to draw back blood from patient but was unable to.Tried to flush iv, unable.Removed iv and restarted new iv.The iv i removed was very difficult to flush outside of the patient--defective iv catheter.

• 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: 16232231
• MDR Text Key: 307989391
• Report Number: 16232231
• 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: 01/19/2023

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 Operator: Health Professional
• Device Model Number: 4252520-02
• Device Catalogue Number: 4252520-02
• Device Lot Number: 22L24G8242
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA
• Patient Sex: Female