MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. ACCUCATH CATHETER THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number AC0182250

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: ACCUCATH CATHETER
• Type of Device: THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT
• MDR Report Key: 10697303
• MDR Text Key: 212109222
• Report Number: MW5097286
• Device Sequence Number: 1
• Product Code: FOZ
• 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

0 Patients were Involved in the Event:

• Date FDA Received: 10/16/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2021
• Device Catalogue Number: AC0182250
• Device Lot Number: REEN1049
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage