MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA WITH MAXZERO; PERIPHERAL IV CATHETERS

Catalog Number 383556

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.

Event Description

It was reported that bd with maxzero had foreign matter inside the needle cover.The following information was provided by the initial reporter: the iv below was opened new and it looks like there is something in the case near the needle.What do i need to do with this piece of equipment? response received 01 nov 2023 are you able to provide the date of the event in the format of dd-mm-yyyy? (b)(6) 2023 kindly confirm the position of the foreign matter; on the needle or near the needle.Inside the iv needle cap was brown/grey substance was there any patient involvement? no if yes, how was the patient outcome? are there any clinical signs, health consequences or impact? no nurse saw substance any sample available for investigation? iv the iv in my office.

Manufacturer Narrative

The complaint of an unexpected material in the needle cover was confirmed and the cause appeared to be manufacturing related due to embedded non-foreign material from the extrusion process.Embedded brown spots in the needle cover were confirmed from the provided photographs and physical sample.The material was not loose or capable of getting in the fluid path.The appropriate manufacturing personnel were notified of this complaint.After investigation it is determined that this is not an mdr reportable event.

Event Description

Na.

• Brand Name: BD NEXIVA WITH MAXZERO
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18235087
• MDR Text Key: 329344340
• Report Number: 1710034-2023-01361
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835561
• UDI-Public: (01)30382903835561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/19/2024
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 383556
• Device Lot Number: 3215553
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1