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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 4252586-02
Device Problem Break (1069)
Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Event Date 02/10/2022
Event Type  malfunction  
Manufacturer Narrative
The report has been identified as b. Braun medical, inc. Internal report (b)(4). The complaint is under evaluation. A follow-up report will be provided after the examination results are available.
 
Event Description
As reported by the user facility: introcan catheter cannula separated. Customer experienced an issue with a retained portion of the catheter in a patient.
 
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Brand NameINTROCAN SAFETY®
Type of DeviceCATHETER,INTRAVASCULAR
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl- braun strabe 1
melsungen, 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl- braun strabe 1
melsungen, 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key13693958
MDR Text Key286767183
Report Number9610825-2022-00062
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier04046963318215
UDI-Public(01)04046963318215
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 Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4252586-02
Device Catalogue Number4252586-02
Device Lot Number21B17G8271
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/08/2022 Patient Sequence Number: 1
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