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

Catalog Number 381044

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the needle retraction of a bd insyte¿ autoguard¿ bc shielded iv catheter failed.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Review of dhr revealed all required challenge samples and set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and adhesive overfilled/drip as well as periodic cleaning/alignment of the glue grippers were performed on various stages throughout the process, all the inspections passed per specifications.Dhr review disclosed no indication of the alleged defect, as there were no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the event description.No significant discoveries were found.Received one opened package from lot 7076888.The opened package contained only the protective needle cover; therefore physical evaluation and testing could not be conducted.Therefore there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the alleged defect.This incident is indeterminate.Investigation samples(s) meet manufacturing specifications: unknown, the unit provided consisted of only the protective needle cover therefore there was insufficient evidence to conduct physical evaluation and testing.Therefore there was no physical/mechanical evidence to confirm or to support manufacturing process related issues for the alleged defect.This incident is indeterminate.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7366344
• MDR Text Key: 103527465
• Report Number: 1710034-2018-00109
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 381044
• Device Lot Number: 7076888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Date Manufacturer Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other