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

Model Number 381423

Device Problems Retraction Problem (1536); Fail-Safe Did Not Operate (4046)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/19/2022

Event Type  malfunction  

Event Description

Iv catheter needle would not retract into safety spring.The nurse inserted the iv, manually pulled the needle from the insertion site.Once the iv site was secured, the nurse tried to push the safety button to retract the needle but it did not work.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BD; 5859 farinon dr., ste 200; san antonio TX 78249
• MDR Report Key: 15498306
• MDR Text Key: 300738633
• Report Number: 15498306
• 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: 09/19/2022

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
• Device Model Number: 381423
• Device Catalogue Number: 381423
• Device Lot Number: 1355613
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/28/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Race: White