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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Inflammation (1932)
Event Date 03/21/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). No sample has been returned for investigation. Without the actual sample or lot number, a thorough investigation can not be performed. All available information has been forwarded to the actual manufacturer. A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): catheter-infection.
 
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Brand NameINTROCAN SAFETY®
Type of DeviceCATHETER,INTRAVASCULAR,THE
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, hessen 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4842408332
MDR Report Key8516316
MDR Text Key142036804
Report Number9610825-2019-00116
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K020785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number4253566-01
Device Lot Number18L14G8272
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2019
Distributor Facility Aware Date04/15/2019
Event Location Hospital
Date Report to Manufacturer07/03/2019
Date Manufacturer Received03/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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