MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. NEXIVA DIFFUSICS; INTRAVASCULAR CATHETER

Catalog Number	383590
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that hard to get blood to draw from these; it would not even flush after the iv was removed; hole on side of catheter noted.Verbatim: i have been getting a few reports that we are having issues with the nexiva diffusics catheters, particularly when trying to flush the catheters.Initially the complaint was ""these are hard to get blood to draw from these.But last night a couple of people came to talk to me about this issue as well.And thinking about it, the main ones i have been called for are the 24 ga diffusics, i can get them to draw most of the time but it takes a whole lot of work, sometimes i cannot get them to draw at all though."" most recently as of last night i had this complaint, ""tonight an iv was in and when the rn tried to flush it she was unable, it would not even flush after the iv was removed."" here is some additional information that was provided,"" while attempting to obtain iv during an ed iv crew call, uv obtained to left wrist.Immediate blood return.When attempting to flush extreme difficulty, flushing iv and unable to flush.When catheter was removed from patient still difficulty flushing.When eventually able to get the flush with extreme strength, hole on side of catheter noted.Potential manufacturing issue? not the fist time i have had this issue with nexiva catheter."" i have some staff that are willing/have asked to speak with you all if you would like that or is this an educational issue that we can tackle? unfortunately i do not have any lot numbers to provide at this time.I have asked staff to please provide them if they are also running into the same issue.".
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: NEXIVA DIFFUSICS
• Common Device Name: 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24809385
• Report Number: 9610847-2026-00158
• Device Sequence Number: 21342774
• Product Code: FOZ
• UDI-Device Identifier: 00382903835904
• UDI-Public: (01)00382903835904(10)5248701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173354
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 383590
• Device Lot Number: 5248701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown