MAUDE Adverse Event Report: IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problem Use of Device Problem (1670)

Patient Problems Hematoma (1884); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

I received iron staining from an infusion of iron iv at (b)(6).The stain appeared far to the right of the inner elbow (on my left arm) where the catheter was placed.The nurse poorly placed the catheter.The catheter was not placed correctly during the first poke and the nurse must have gone through the vein.(i can't remember if she fished around a little after insertion.) she pulled the catheter almost all the way out before placing it back in.The vein was the very superficial vein and it was very small.There was pain during the administration.The nurse said there was nothing abnormal when it was mentioned.Afterwards a very tight coban bandage was wrapped around my arm many times.Fda safety report id# (b)(4).

• Brand Name: IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 14696414
• MDR Text Key: 294296663
• Report Number: MW5110339
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1