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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
Catalog Number 4252500-02
Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Patient Problem Needle Stick/Puncture (2462)
Event Date 02/12/2014
Event Type  malfunction  
Event Description
As reported by the user facility: customer reports that safety clip did not engage and it remained lodged in the catheter.No sample available.Resulted in an exposed sharp and a second iv stick to the customer.
 
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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
carl-braun str. 1
melsungen D-342-12
MDR Report Key3722014
MDR Text Key4307667
Report Number2523676-2014-00030
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type Unknown
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/26/2014,02/18/2014
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 Expiration Date04/01/2018
Device Catalogue Number4252500-02
Device Lot Number3D28258303
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2014
Distributor Facility Aware Date02/18/2014
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer02/26/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/26/2014
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
Patient Sequence Number1
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