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

Model Number 382534

Device Problems Retraction Problem (1536); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/13/2022

Event Type  malfunction  

Event Description

Nurse attempted to place a peripheral intravenous catheter for the patient with a bd insyte autoguard bc shielded iv catheter in the patients arm.She was unsuccessful.On retracting the needle from the patients arm she notice that the plastic canula that is connected to the pink portion of the device was completely broken off inside the patient's arm.Unable to retrieve the cannula.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 15274649
• MDR Text Key: 298407083
• Report Number: 15274649
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 382534
• Device Catalogue Number: 382534
• Device Lot Number: 2101813
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Weight: 51 KG