MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS 20G X 1.00 IN INTRAVASCULAR CATHETER

Catalog Number 383593

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

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 during use the needle went through the catheter with a bd nexiva diffusics 20g x 1. 00 in. The following information was provided by the initial reporter: the plastic over the needle has partially pulled apart from the needle.

• Brand Name: BD NEXIVA DIFFUSICS 20G X 1.00 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8945416
• MDR Text Key: 156407267
• Report Number: 9610847-2019-00545
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173354
• 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,Followup
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 383593
• Device Lot Number: 9056970
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/29/2019 Patient Sequence Number: 1