MAUDE Adverse Event Report: B BRAUN B BRAUN INTROCAN SAFETY 3 CLOSED IV CATHETER 20G X 1 IN.; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number REF 4251129-02

Device Problems Difficult or Delayed Positioning (1157); Difficult to Flush (1251); Product Quality Problem (1506); Material Twisted/Bent (2981)

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

Event Date 08/23/2022

Event Type  malfunction  

Event Description

This facility just introduced this new iv catheter product, unable to thread iv catheter into final position despite appropriate insertion angle, and double blood return confirmation.Same pt after successful iv insertion was discovered to have kinked some time later when attempting to flush.This facility has seen increased issues as such with new product being introduces in service.Fda safety report id #(b)(4).

• Brand Name: B BRAUN INTROCAN SAFETY 3 CLOSED IV CATHETER 20G X 1 IN.
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B BRAUN; bethlehem PA 18018
• MDR Report Key: 15311416
• MDR Text Key: 298978192
• Report Number: MW5111757
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/25/2022

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: REF 4251129-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American