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

Model Number 382523

Device Problems Device Difficult to Setup or Prepare (1487); Failure to Advance (2524); Material Split, Cut or Torn (4008)

Patient Problem Laceration(s) (1946)

Event Date 10/11/2022

Event Type  malfunction  

Event Description

Narrative from staff: the sheath of iv had been sheared by the needle before placement.The iv placement was attempted.Once the skin and vein were pierced with the needle, staff were unable to thread catheter and realized the needle had come out through part of the catheter and that was why they could not thread catheter.The sheath was sheared approx.1 mm from end.Staff immediately removed needle and placed pressure on site with 2x2.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 15679412
• MDR Text Key: 302492771
• Report Number: 15679412
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2022

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: 382523
• Device Catalogue Number: 382523
• Device Lot Number: 2146301
• 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: 10/14/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Sex: Female
• Patient Weight: 54 KG