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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY I.V. SAFETY CATHETER

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B. BRAUN MELSUNGEN AG INTROCAN® SAFETY I.V. SAFETY CATHETER Back to Search Results
Model Number 4251601-020
Device Problem Protective Measures Problem (3015)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b. Braun internal report number (b)(4): the complaint is still under investigation. A follow-up report will be provided, as soon as investigation has been completed. Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b. Braun medical, inc.
 
Event Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6): "catheter damaged. " "after placing the catheter on the patient's arm, the mandrel safety did not trigger. By throwing away the waste, the caregiver pricked himself with the mandrel which was then unsecured. ".
 
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Brand NameINTROCAN® SAFETY
Type of DeviceI.V. SAFETY CATHETER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, hessen 34212
GM 34212
Manufacturer (Section G)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key12623508
MDR Text Key276129022
Report Number9610825-2021-00431
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K982805
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4251601-020
Device Catalogue Number4251628-01
Device Lot Number20M18G8315
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2020
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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