MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; CATHETER, INTRAVENOUS, SHORT TERM

Catalog Number 382512

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 01/22/2016

Event Type  malfunction  

Event Description

The 24 gauge angio catheters have been loosening from the microbore extension tubing.Multiple times after they have been flushed, taped down and reflushed, they leak within minutes and have to be completely untaped and found to be loosening from the tubing.On one occasion the iv was completely lost.No problems noted with microbore tubing and 22 gauge angiocaths.This has been noted with more than one lot # as well.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: CATHETER, INTRAVENOUS, SHORT TERM
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 5403730
• MDR Text Key: 37281617
• Report Number: 5403730
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 382512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other