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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE Back to Search Results
Model Number 4252500-02
Device Problem Leak/Splash (1354)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/04/2022
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical internal report number (b)(4). No sample and/or lot number were provided. Further investigation of the complaint is not possible without a sample and/or lot number. The actual defective device is valuable tool in investigating the cause of this incident. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If any additional pertinent information becomes available, a follow up will be submitted.
 
Event Description
As reported by the user facility: detailed inquiry description rn was inserting piv. When advancing catheter, rn noticed hole in catheter (patient's blood was leaking out of the side of the catheter). Catheter removed intact and discarded. Piv initiated with new catheter. No injury reported.
 
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Brand NameINTROCAN SAFETY®
Type of DeviceCATHETER,INTRAVASCULAR,THE
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
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key14495350
MDR Text Key292587993
Report Number9610825-2022-00178
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier04046963165963
UDI-Public(01)04046963165963
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4252500-02
Device Catalogue Number4252500-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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