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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3 CATHETER,INTRAVASCULAR,THE Back to Search Results
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).
 
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Brand NameINTROCAN SAFETY® 3
Type of DeviceCATHETER,INTRAVASCULAR,THE
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
MDR Report Key9371102
MDR Text Key167865572
Report Number2532083-2019-00006
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/25/2019
Distributor Facility Aware Date10/30/2019
Event Location Hospital
Date Report to Manufacturer11/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/25/2019 Patient Sequence Number: 1
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