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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY INTRODUCER, CATHETER

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B. BRAUN MEDICAL INC. INTROCAN SAFETY INTRODUCER, CATHETER Back to Search Results
Model Number 4252500-02
Device Problems Physical Resistance (2578); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2017
Event Type  malfunction  
Event Description
The nurse was attempting to start an iv on a patient in the neonatal intensive care unit (nicu). When she was trying to place the iv, she had difficulty threading the catheter and felt like it was catching whenever attempts were made to thread the catheter. She pulled the catheter and used a different one without incident. Packaging and catheter saved.
 
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Brand NameINTROCAN SAFETY
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 m arcon blvd
allentown PA 18109
MDR Report Key7124255
MDR Text Key95062964
Report Number7124255
Device Sequence Number0
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 12/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2022
Device Model Number4252500-02
Device Catalogue Number4252500-02
Device Lot Number17G16G8272
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2017
Event Location Hospital
Date Report to Manufacturer12/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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