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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC INTROCAN SAFETY CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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B. BRAUN MEDICAL INC INTROCAN SAFETY CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 4252535-02
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2017
Event Type  malfunction  
Event Description
A 20 g iv cannulas lot # 16n10g8392. Several staff members on several occasions are not getting blood flash in good veins. They have then gone on to use size 18 in the same vein without any problem.
 
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Brand NameINTROCAN SAFETY
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
B. BRAUN MEDICAL INC
paul o'connell
824 12th ave.
bethlehem PA 18018
MDR Report Key7154247
MDR Text Key96037243
Report Number7154247
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/05/2017,11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/01/2021
Device Model Number4252535-02
Device Catalogue Number4252535-02
Device Lot Number16N10G8392
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/05/2017
Event Location Hospital
Date Report to Manufacturer09/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/29/2017 Patient Sequence Number: 1
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