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

Model Number 24GX 3/4"

Device Problems Product Quality Problem (1506); Improper Flow or Infusion (2954); Unintended Movement (3026); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

The iv catheters we currently use are not the same as the past, possibly a different brand.The needle turns around within the catheter.This makes it difficult to keep orientation of the needle bevel as the needle is advanced.Also, i get no flashback of blood into the needle chamber despite the needle/catheter positioned inside the vein lamen.In those cases, if i remove the needle, then i get blood in the catheter.This happens 20% of the time.I want a variety of different iv catheter companies to try.The original company i used also.Please forward my complaint to the mfr.They are required to notify the fda of complaints on devices they manufacture.

• Brand Name: EXEL SAFELET CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): EXEL INTERNATIONAL
• MDR Report Key: 16094528
• MDR Text Key: 306694352
• Report Number: MW5114140
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24GX 3/4"
• Device Catalogue Number: 26757
• Device Lot Number: 201122
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other