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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 4251644-02
Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2014
Event Type  malfunction  
Event Description
As reported by the user facility: customer reports safety clip did not properly deploy.No pt injury.
 
Manufacturer Narrative
(b)(4).The actual device has not been received and the investigation is ongoing at this time.A f/u report will be submitted when the investigation results become available.(b)(4).
 
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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
carl-braun-str.1
melsungen D-342-12
GM   D-34212
661712769
MDR Report Key4290403
MDR Text Key5057022
Report Number9610825-2014-00410
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 11/11/2014,10/23/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4251644-02
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2014
Distributor Facility Aware Date10/23/2014
Event Location Hospital
Date Report to Manufacturer11/11/2014
Date Manufacturer Received10/23/2014
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
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