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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 4252519-02
Device Problem Failure to Advance (2524)
Patient Problem Insufficient Information (4580)
Event Date 07/26/2020
Event Type  malfunction  
Event Description
Attempted to place 22g piv. Pierced skin but unable to advance catheter any further x2. Placed #24g piv without difficulty on first attempt. Catheters with the same lot number removed from floor circulation.
 
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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.
901 marcon blvd
allentown PA 18109
MDR Report Key12127432
MDR Text Key260266044
Report Number12127432
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4252519-02
Device Catalogue Number4252519-02
Device Lot Number20M03G8362
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2021
Event Location Hospital
Date Report to Manufacturer07/07/2021
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?
Type of Device Usage Unkown

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