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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE

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B. BRAUN MEDICAL INC. INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THE Back to Search Results
Model Number 4252535-02
Device Problem Leak/Splash (1354)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/19/2022
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun medical internal report number (b)(4). The investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
 
Event Description
As reported by the user facility: event 3: it was reported that the seal of the catheter is defective. We had to place iv's several times on several different patients and they were leaking all over the pt. We thought it was the transfer device for blood at first because we could not get suction to draw the bloods. Then we tried putting the extension tube to the catheter and it was leaking all over. We tried all the different lot number of the 20g and this particular lot number was the only defective ones. No injury reported.
 
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Brand NameINTROCAN SAFETY®
Type of DeviceCATHETER,INTRAVASCULAR,THE
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
901 marcon blvd.
allentown PA 18109
Manufacturer Contact
jonathan severino
901 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key14075111
MDR Text Key289100737
Report Number2523676-2022-00152
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier04046963165925
UDI-Public(01)04046963165925
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,Followup,Followup
Report Date 05/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4252535-02
Device Catalogue Number4252535-02
Device Lot Number0061801062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2022
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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