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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
Catalog Number 4252535-02
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Date 04/15/2024
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400653090.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: the needle broke in the patient angio sheared from the needle patient was fine but complaining of pain.
 
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Brand Name
INTROCAN SAFETY®
Type of Device
CATHETER,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 Key19200829
MDR Text Key341665922
Report Number2523676-2024-00407
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4252535-02
Device Lot Number0061918660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2024
Initial Date FDA Received04/29/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/09/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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