MAUDE Adverse Event Report: EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2020

Event Type  malfunction  

Event Description

In radiology bay 12 i was called to place an 18g in the rac.I had to use ultrasound.My first attempt failed and so with my second attempt i used an 18g accucath.Before insertion i checked the guidewire and it functioned properly.During insertion i visualized the tip of the needle in the vessel and then when i tried to advance the guidewire it would not advance at all, it just would not even budge.So i tried just advancing the catheter without the guidewire, and it slid in and blood began to come out around the needle.When i pressed the button to retract the needle it did not retract at all.I removed the needle from the catheter slowly and again there was some blood coming out.I then thought i was in the vein with a successful iv and connected the extension set with an empty 3cc syringe on it to obtain a blood sample.I was not able to draw back any blood at all.I attempted a few times without success, so then i removed the 3cc syringe and connected a flush and the catheter would not flush at all.I removed the catheter expecting to see a kink or something to explain this but there was nothing wrong with the catheter.Even after it was removed from the patient i was not able to flush it.I believe the accucath and the extension set both malfunctioned.Fda safety report id# (b)(4).

• Brand Name: EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 10697303
• MDR Text Key: 212109222
• Report Number: MW5097286
• Device Sequence Number: 3
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• 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 Number: 1
• Patient Age: 48 YR
• Patient Weight: 114