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

Catalog Number 381034

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters had a foreign "plastic particle" attached to the end of their catheters that was easily removed.As reported by the customer, translated from french to english, "small plastic particle at the end of the catheter that is easily detached.".

Event Description

It was reported that 2 bd insyte¿ autoguard¿ bc shielded iv catheters had a foreign "plastic particle" attached to the end of their catheters that was easily removed.As reported by the customer, translated from french to english, "small plastic particle at the end of the catheter that is easily detached.".

Manufacturer Narrative

Investigation: review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.No samples or photos were provided for this incident.The alleged defect was not identified or confirmed and a root cause was not established.

• 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: 8391354
• MDR Text Key: 137969016
• Report Number: 1710034-2019-00251
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 381034
• Device Lot Number: 8214986
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other