MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

As reported by user facility: reports customer is stating there is an increase in blood stream infections in the facility since using the introcan safety 3.(b)(4).

• Brand Name: INTROCAN SAFETY® 3
• Type of Device: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 9371102
• MDR Text Key: 167865572
• Report Number: 2532083-2019-00006
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 11/25/2019
• Distributor Facility Aware Date: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention