• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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  malfunction  
Manufacturer Narrative
(b)(4). The investigation into this reported event is ongoing. Additional attempts to receive a sample and get more information are being made. A follow-up report will be submitted when the results of the investigation are available.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINTROCAN SAFETY® 3
Type of DeviceCATHETER,INTRAVASCULAR,THE
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, 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 Key9371113
MDR Text Key167865582
Report Number9610825-2019-00533
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/26/2019
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/30/2019
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

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