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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY CATHETER,INTRAVASCULAR

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY CATHETER,INTRAVASCULAR Back to Search Results
Model Number 4253566-02
Device Problems Fail-Safe Problem (2936); Device Handling Problem (3265)
Patient Problem Needle Stick/Puncture (2462)
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical inc. Internal report number (b)(4). The investigation into this reported event is ongoing. Additional attempts to receive the device involved in the reported event are being made. A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by user facility: safety on catheter did not engage which resulted in needlestick.
 
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Brand NameINTROCAN SAFETY
Type of DeviceCATHETER,INTRAVASCULAR
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, hessen 34212
GM 34212
Manufacturer (Section G)
B.BRAUN MEDICAL AG
seesatz 17
sempach 6204
SZ 6204
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key11798585
MDR Text Key267720364
Report Number9610825-2021-00157
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier04046963318253
UDI-Public(01)04046963318253
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4253566-02
Device Catalogue Number4253566-02
Device Lot Number20D01G8261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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