MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE AUTOGUARD SHIELDED IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Patient Problems Failure of Implant (1924); Needle Stick/Puncture (2462)

Event Date 07/21/2023

Event Type  malfunction  

Event Description

Nurse was starting iv on patient, as they attempted to advance catheter it became stuck and would not advance.Nurse attempted to start iv in a separate location with a new needle, as she started to advance the catheter, the plastic sheath bent and would not advance into the vein.

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 17572185
• MDR Text Key: 321438213
• Report Number: 17572185
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male