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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 4251628-02
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 the user facility: the safety on this needle did not activate and this resulted in a needle stick and exposure to one of the nurses. While holding pressure on the site, i attempted to move the needle away from the patient and did not notice that the needle tip was not covered by the safety shield. I grabbed the needle at the hub with my thumb and index finger but was stuck in my ring finger of the same hand.
 
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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 MELSUNGEN AG
carl-braun-str. 1
melsungen, hessen 34212
GM 34212
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key11260008
MDR Text Key249060970
Report Number9610825-2021-00006
Device Sequence Number1
Product Code FOZ
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 distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4251628-02
Device Catalogue Number4251628-02
Device Lot Number20H12G8302
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2020
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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