MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY; INTRODUCER, CATHETER

Model Number 4252500-02

Device Problems Physical Resistance (2578); Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2017

Event Type  malfunction  

Event Description

The nurse was attempting to start an iv on a patient in the neonatal intensive care unit (nicu).When she was trying to place the iv, she had difficulty threading the catheter and felt like it was catching whenever attempts were made to thread the catheter.She pulled the catheter and used a different one without incident.Packaging and catheter saved.

• Brand Name: INTROCAN SAFETY
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 m arcon blvd; allentown PA 18109
• MDR Report Key: 7124255
• MDR Text Key: 95062964
• Report Number: 7124255
• Device Sequence Number: 0
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2022
• Device Model Number: 4252500-02
• Device Catalogue Number: 4252500-02
• Device Lot Number: 17G16G8272
• 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: 12/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1