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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INDUSTRIES SDN. BHD. INTROCAN SAFETY 3 CLOSED IV CATHETER 20 G X 1 INCH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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B. BRAUN MEDICAL INDUSTRIES SDN. BHD. INTROCAN SAFETY 3 CLOSED IV CATHETER 20 G X 1 INCH CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Lot Number 21L1168935
Device Problems Material Twisted/Bent (2981); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Event Description
Shortly after inserting a new 20 g iv the fluids stopped flowing through the catheter and i was unable to obtain a blood return. This occurred after pt bent her arm. The catheter was removed and found to be kinked. Fda safety report id# (b)(4).
 
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Brand NameINTROCAN SAFETY 3 CLOSED IV CATHETER 20 G X 1 INCH
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
MDR Report Key13783001
MDR Text Key287427663
Report NumberMW5108179
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number21L1168935
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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