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

Model Number 20G

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

Patient was having a ct chest/abd/pelvis with iv contrast.The 20g iv was in the antecubital (ac) and was not able to be used due to a malfunction of the catheter.It was leaking blood and fluids around the hub of the plastic braun catheter.This is the second time in two days from this lot.

• Brand Name: INTROCAN SAFETY IV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 4154884
• MDR Text Key: 4930328
• Report Number: 4154884
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2014

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: Invalid Data
• Device Model Number: 20G
• Device Catalogue Number: 4252543-02
• Device Lot Number: 4C29258372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 57