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

Model Number 4251620-02

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2021

Event Type  malfunction  

Event Description

Introcan safety® deep access iv catheter, 18ga, 2.5in.Leaked at hub when connecting j loop.Two different j loops were tried, iv discontinued and new site established with new equipment, no further issues.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 12391233
• MDR Text Key: 269390248
• Report Number: 12391233
• 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
• Type of Report: Initial
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4251620-02
• Device Catalogue Number: 4251620-02
• Device Lot Number: 21B12G8371
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/23/2021
• Date Report to Manufacturer: 08/31/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33945 DA