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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY; I.V. SAFETY CATHETER

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY; I.V. SAFETY CATHETER Back to Search Results
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2014
Event Type  malfunction  
Event Description
(b)(4).
 
Manufacturer Narrative
(b)(4).All available information was forwarded to the actual manufacturer, braun (b)(4) and their investigation is on gong at this time.A follow up report will be provided when the investigation results become available.
 
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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, officer
carl-braun-str.1
melsungen D-342-12
GM   D-34212
661712769
MDR Report Key3771193
MDR Text Key4377136
Report Number9610825-2014-00093
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K982805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Remedial Action Other
Type of Report Initial
Report Date 03/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Date Manufacturer Received03/31/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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