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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY 24G X 3/4" INTRODUCER, CATHETER

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B. BRAUN MEDICAL INC. INTROCAN SAFETY 24G X 3/4" INTRODUCER, CATHETER Back to Search Results
Model Number 4252500-02
Device Problems Defective Device (2588); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/10/2022
Event Type  malfunction  
Event Description
Rn opened a new introcan safety iv catheter, 24g, from the package and found it bent and unusable. No patient involved.
 
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Brand NameINTROCAN SAFETY 24G X 3/4"
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
824 twelfth avenue
bethlehem PA 18018
MDR Report Key14874272
MDR Text Key295055705
Report Number14874272
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number4252500-02
Device Catalogue Number4252500-02
Device Lot Number21N26G8315
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2022
Event Location Hospital
Date Report to Manufacturer06/30/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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