MAUDE Adverse Event Report: B.BRAUN B.BRAUN INTROCAN SAFETY; SAFETY IV CATHETER

Lot Number 16A26G8303

Device Problems Bent (1059); Out-Of-Box Failure (2311)

Patient Problem No Information (3190)

Event Date 06/13/2016

Event Type  malfunction  

Event Description

Procedure center director reported product removed from packaging.Needle noted to be bent at an angle prior to insertion.

• Brand Name: B.BRAUN INTROCAN SAFETY
• Type of Device: SAFETY IV CATHETER
• Manufacturer (Section D): B.BRAUN
• MDR Report Key: 5737925
• MDR Text Key: 47905292
• Report Number: MW5062943
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2021
• Device Lot Number: 16A26G8303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1