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

Model Number AC0202250

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2019

Event Type  malfunction  

Event Description

Immediately after insertion of accucath, catheter visualized by ultrasound in the center of the vessel. Catheter advanced. No blood return, no flushing. Pulled out catheter to find it kinked. Catheter saved.

• Brand Name: PERIPHERAL CATHETER INSERTION KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 8934741
• MDR Text Key: 155647284
• Report Number: 8934741
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/13/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/27/2019
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage