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 INTRAOCAN 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 INTRAOCAN SAFETY; I.V. SAFETY CATHETER Back to Search Results
Catalog Number 4251644-02
Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2013
Event Type  malfunction  
Event Description
As reported by the user facility through medwatch: nurse had started iv on pt.Afterwards, while cleaning up the supplies, she was stuck with the tip of the contaminated iv needle, which had a malfunctioning safety cover.Medwatch no.: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTRAOCAN 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 (Section G)
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown PA 18109 934
Manufacturer Contact
901 marcon blvd.
allentown, PA 18109-9341
MDR Report Key3610015
MDR Text Key4089965
Report Number2523676-2013-00438
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/14/2014,12/30/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4251644-02
Device Lot Number3G7258395
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/09/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/14/2014
Distributor Facility Aware Date12/30/2013
Event Location Hospital
Date Report to Manufacturer01/14/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/13/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
-
-