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

Model Number 4252535-02

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/23/2017

Event Type  malfunction  

Event Description

A 20 g iv cannulas lot # 16n10g8392.Several staff members on several occasions are not getting blood flash in good veins.They have then gone on to use size 18 in the same vein without any problem.

• Brand Name: INTROCAN SAFETY
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC; paul o'connell; 824 12th ave.; bethlehem PA 18018
• MDR Report Key: 7154247
• MDR Text Key: 96037243
• Report Number: 7154247
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2017,11/27/2017

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: No Information
• Device Expiration Date: 12/01/2021
• Device Model Number: 4252535-02
• Device Catalogue Number: 4252535-02
• Device Lot Number: 16N10G8392
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other