MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD NEXIVA DIFFUSICS; PERIPHERAL IV CATHETERS

Catalog Number 383590

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd nexiva diffusics tubing kinks after crimping.The following information was provided by the initial reporter: twice they had to reinsert a new unit because the line was crimped closed by the little blue mechanism you use to close the flow on the line to the needle.I'm not an engineer nor do i profess to know anything about your supplies.However it looks to me like you need to make the line (tubing) from the base of the nexiva diffusics to the needle more pliable so it will not crimp the line you're using.Plus maybe the little blue shutoff needs some redesign.When the blue crimp is shut off, it makes the line stay crimped.Maybe you could use a softer tube and a shutoff designed to not crimp the line.I realize you want to stop or hold back the flow, however what you are using sometimes is only good for one infusion.I was told that the unit was to allow me to be able to get three infusions and then change out to another unit.I had to have two sessions of a 10 day infusion of invanz.On my first 10 days one of the units had to be changed on the third day because it would not let the fluid flow through at the crimped area where the stop value was used.I am on my second 10 day order and the original unti had to be changed out on the second day because of the same thing.I'm just a patient but i thought i would send this to you to see if there could be improvements made.Also, if i'm charged for every unit they use, i will have extra charges, plus be stuck more than i should be.

Event Description

I was an outpatient at the time and i am unable to obtain the item that was used on me.However i was just passing along some information and areas of concern i had with the item.I have attached a copy of the cover that came off the package below.I don't mean to cause any problem, but just wanted to let you know that having to be stuck twice because of the line, it needs to be evaluated.The little blue value mashes the line together and it seems to form closed when the blue value is opened.This only happened on three occasions with me.

Manufacturer Narrative

Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of tubing kinked was not confirmed upon inspection of the photo.The reported failure mode could not be observed in the supplied sample photo.Bd cannot confirm the cause of the failure since no sample was returned for evaluation.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.

• Brand Name: BD NEXIVA DIFFUSICS
• Type of Device: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18920612
• MDR Text Key: 337856898
• Report Number: 9610847-2024-00057
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835905
• UDI-Public: (01)30382903835905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2024

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: Lay User/Patient
• Device Catalogue Number: 383590
• Device Lot Number: 3247112
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1