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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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B. BRAUN MEDICAL INC. INTROCAN SAFETY® CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 4251652-02
Device Problem Material Twisted/Bent (2981)
Patient Problem Insufficient Information (4580)
Event Date 09/29/2021
Event Type  malfunction  
Event Description
Braun introcan safety® iv catheter was bent when removed from the sleeve, cover.
 
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Brand NameINTROCAN SAFETY®
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 12th ave
bethlehem PA 18018
MDR Report Key12631420
MDR Text Key276369053
Report Number12631420
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4251652-02
Device Catalogue Number4251652-02
Device Lot Number21D11G8301
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2021
Event Location No Information
Date Report to Manufacturer10/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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