MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE AUTOGUARD IV CATHETER 20G X 1.16"; INTRAVASCULAR CATHETER

Catalog Number 381434

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Tissue Damage (2104)

Event Date 09/23/2014

Event Type  Injury  

Event Description

It was reported that a nurse used a 20 gauge x 1.16 inch bd insyte autoguard iv catheter to start an iv and draw blood.As the nurse pulled the catheter back the tip of the catheter broke off inside the patient's vein.Fluoroscopy was required to visualize the retained piece of catheter and a vein cut down surgery was done to remove it.

Manufacturer Narrative

A sample is available for evaluation.Upon receipt of the sample and completion of the investigation, a supplemental report will be filed.Pir # (b)(4).

• Brand Name: BD INSYTE AUTOGUARD IV CATHETER 20G X 1.16"
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: aaron larson ; one becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4290775
• MDR Text Key: 5272081
• Report Number: 2243072-2014-00270
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 381434
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Weight: 68