MAUDE Adverse Event Report: BD SUZHOU (MDS) NEXIVA DIFFUSICS; INTRAVASCULAR CATHETER

Catalog Number	383596
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd nexiva diffusics w/maxzero 22g x 1.00 in safety shield activation failed it was reported by the customer that was trying to safety the needle after placing the iv.The customer heard the click of the safety features activating and the needle locking.When trying to remove the needle from the catheter by pulling on the white he could not remove the needle despite the needle being locked and he was not holding the grey in place with the catheter.The customer is very familiar with these catheters, and it happened 3 times with the 22g dffx.Customer was trying to safety the needle after placing the iv.The customer heard the click of the safety features activating and the needle locking.When trying to remove the needle from the catheter by pulling on the white he could not remove the needle despite the needle being locked and he was not holding the grey in place with the catheter.The customer is very familiar with these catheters, and it happened 3 times with the 22g dffx.383596, 5189322.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo and 6 unused physical samples submitted for evaluation.The reported issue of safety shield activation failure was not confirmed upon inspection of the samples.Analysis of the photo showed that the device is observed with the safety system activated but was not removed from the catheter adapter.Evaluation of the 6 physical samples showed no damage or defect was observed.Bd could not determine a manufacturing related root cause since the reported defect was not confirmed during the evaluation of the sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: NEXIVA DIFFUSICS
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• 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: 24146447
• Report Number: 9610847-2026-00022
• Device Sequence Number: 9210897
• Product Code: FOZ
• UDI-Device Identifier: 00382903835966
• UDI-Public: (01)00382903835966(10)5189322
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233529
• 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): 03/12/2026

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: 383596
• Device Lot Number: 5189322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown