MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC ANGIOCATH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS

Catalog Number 382533

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/09/2018

Event Type  malfunction  

Event Description

A 20 gauge bd iv catheter was going to be used on a pre-op patient when the rn noted a burr on the side of the plastic portion of the angiocath.The product was not used on the patient.

• Brand Name: BD INSYTE AUTOGUARD BC ANGIOCATH
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ; sandy UT 84070
• MDR Report Key: 7518204
• MDR Text Key: 108610642
• Report Number: MW5077244
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 382533
• Device Lot Number: 7240674
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1