MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEM BD INSYTE AUTOGARD; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 20 GA. 1.16 IN

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Type  No Answer Provided  

Event Description

A 20ga iv cannula was broken at the end of needle.Iv was not inserted in the pt's hand.Upon attempted insertion of needle it bent at the end before breaking skin.

• Brand Name: BD INSYTE AUTOGARD
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEM
• MDR Report Key: 7762480
• MDR Text Key: 116621588
• Report Number: MW5078936
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 20 GA. 1.16 IN
• Device Lot Number: 8092781
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1