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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/21/2020
Event Type  Injury  
Event Description
The patient came into ct suite from the emergency room for a ct angiogram of the chest with contrast.After consent was obtained, the patient's iv line was checked for patency by flushing the line with normal saline and connected to the syringe containing contrast medication in the power injector.Once the exam was started and contrast injection started, it was noticed that the luer-lock of the syringe in the injector had broken off and the contrast material had emptied onto the patient, table and floor.A second attempt was made using a new injector syringe filled with contrast material, but this time the iv catheter in the patient's arm failed.No harm happened to the patient, but exam was not able to be completed as ordered.Ref# (b)(4).
 
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Brand Name
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key10032282
MDR Text Key190322985
Report NumberMW5094402
Device Sequence Number2
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 Administrator/Supervisor
Type of Report Initial
Report Date 05/01/2020
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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