Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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; I.V. SAFETY CATHETER
  • 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; I.V. SAFETY CATHETER Back to Search Results
Catalog Number 4251601-03
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Patient Involvement (2645)
Event Date 08/06/2014
Event Type  malfunction  
Event Description
As reported by the user facility (translation of user facility info by bbm sales organization in (b)(4)): the safety shield didn't automatically cover the needle tip as withdraw needle exited the catheter hub.
 
Manufacturer Narrative
(b)(4).The device is currently shipping from (b)(6) to the mfr for investigation.A follow up report will be provided when the inspection results become available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTROCAN SAFETY
Type of Device
I.V. SAFETY CATHETER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str.1
melsungen 3421 2
GM  34212
Manufacturer Contact
ludwig schuetz, safety officer
carl-braun-str.1
melsungen D-342-12
GM   D-34212
661712769
MDR Report Key4071951
MDR Text Key20862286
Report Number9610825-2014-00326
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K982805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 08/26/2014,08/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4251601-03
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2014
Distributor Facility Aware Date08/12/2014
Event Location Hospital
Date Report to Manufacturer08/26/2014
Date Manufacturer Received08/12/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-