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

Catalog Number	383598
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
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 needle retraction failed it was reported by the customer that the safety mechanism did not activate.It was still nested in the white needle holder and they had to physically pull the plastic box down to the needle tip, and it still didn¿t catch, so they pulled it down with more force and it held.Rcc received a complaint via email.I am writing to let you know of a needle safety mechanism failure i experienced this morning.I placed a 22g 1 ¾ in.Piv this morning and the safety mechanism did not activate.It was still nested in the white needle holder and i had to physically pull the plastic box down to the needle tip, and it still didn¿t catch, so i pulled it down with more force and it held.The catheter packaging is pictured below.Please let me know if you need anymore information.I have saved the needle if you need it.Item# 383598, lot# 5247921.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo and 1 physical sample submitted for evaluation.The reported issue of needle retraction failure was confirmed upon inspection of the samples.Analysis of the sample showed that it was observed that a component that is causing the reported failure is missing from the device received.Bd determined that the cause of the failure was attributed to the manufacturing process.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 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: 24132921
• Report Number: 9610847-2026-00019
• Device Sequence Number: 10343847
• Product Code: FOZ
• UDI-Device Identifier: 00382903835980
• UDI-Public: (01)00382903835980(11)250924(17)280831(10)5247921
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 383598
• Device Lot Number: 5247921
• 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: 12/31/2025
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown