BD INSYTE AUTOGUARD 382633

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for BD INSYTE AUTOGUARD 382633 manufactured by Becton, Dickinson And Company.

Event Text Entries

[184848444] After intravenous (iv) catheter was inserted, the nurse validated blood return upon iv placement. As the nurse was attempting to advance the iv catheter, there was a noticeable resistance upon entry into the vein. The nurse was unable to place the iv as the vein was punctured. After removing the iv catheter, the nurse assessed the needle and noticed that it had punctured through the side of the plastic tube of the iv catheter.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9877359
• MDR Report Key: 9877359
• Date Received: 2020-03-25
• Date of Report: 2020-02-20
• Date of Event: 2020-02-18
• Report Date: 2020-02-20
• Date Reported to FDA: 2020-02-20
• Date Reported to Mfgr: 2020-03-25
• Date Added to Maude: 2020-03-25
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD INSYTE AUTOGUARD
• Generic Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Product Code: FOZ
• Date Received: 2020-03-25
• Model Number: 382633
• Catalog Number: 382633
• Lot Number: 9331221
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON AND COMPANY
• Manufacturer Address: 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-25