MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number 382633

Device Problem Retraction Problem (1536)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/25/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported bd insyte¿ autoguard¿ bc winged shielded iv catheter blood control technology 20ga 1.00in needle partially retracted leaving a risk of needle stick.The following information was provided by the initial reporter: "attempted iv start with 20g insyte autoguard bc winged.Pt's veins were easily alpable and visible.Pt was alert, oriented and cooperative.No difficulty in getting flash initially, but as seems to be a consistent problem with this type of iv, the needle retraction rendered the plastic cannula flimsy and impossible to thread into the vein.On reattempt, the needle was left in place and cannula advanced slightly over the needle before it was auto-retracted; however, this left the needle end exposed and a very real risk of dirty needle stick ensued, and the cannula could not be threaded anyway as it was too flimsy and simply folded in on itself.In the end, it was only with a bd nexiva closed iv catheter system that a successful iv start was done on what should have been an uncomplicated, quick iv start.".

• Brand Name: BD INSYTE AUTOGUARD BC WINGED SHIELDED IV CATHETER BLOOD CONTROL TECHNOLOGY
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12256827
• MDR Text Key: 264562203
• Report Number: 1710034-2021-00652
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903826330
• UDI-Public: 30382903826330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 382633
• Device Catalogue Number: 382633
• Device Lot Number: 9347499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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 Age: 119 YR