MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD WINGED 20 GA X 1.16 IN; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 381534

Device Problem Disconnection (1171)

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

Event Date 02/13/2020

Event Type  malfunction  

Event Description

The nurse inserted the iv catheter into the patient and advanced the catheter into the patient.Prior to removing the needle from the catheter, she depressed the white button to retract the needle.Instantaneously as the needle retracted, the catheter, including the metal piece that holds the catheter inside the pink hub, propelled forward into the patient's vein.The silver metal piece was barely visible under the skin.The catheter and hub were completely disconnected.The nurse held pressure immediately at the distal end of the catheter and was able to "hook" the metal and retrieve the catheter from inside the patient upon inspection, the catheter tubing was intact with no retained pieces left inside the patient.

• Brand Name: BD INSYTE AUTOGUARD WINGED 20 GA X 1.16 IN
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 9818323
• MDR Text Key: 183156446
• Report Number: 9818323
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 381534
• Device Catalogue Number: 381534
• Device Lot Number: 9325479
• 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: 02/14/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30295 DA