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

Catalog Number	383532
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It falls off during insertion of the needle and sometimes even during administration of the chemo.Response received on: (b)(6) 2026 was the device being used in/on patient when the issue occurred? yes, when the needle is inserted into the patient, the cap sometimes falls off.Was patient or user harmed? if yes, please explain yes, blood loss during needle insertion and when the cap falls off during the chemo injection, chemo will get on the skin and clothing.Was the hcp present when the issue occurred? yes, when inserting the needle.No, if the patient has gone to the toilet and the cap comes loose there.If leakage occurred, please confirm the fluid that leaked.Blood or iv fluid or chemo.Was additional medical intervention/medication required? if yes, please explain no.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 383532 and lot number 5239531.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported issue, and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect similar issues during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Event date has been changed to "unknown".

• Brand Name: NEXIVA
• Common Device Name: 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: 24221397
• Report Number: 1710034-2026-00085
• Device Sequence Number: 9366395
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: (01)00382903835324(11)250828(17)280831(10)5239531
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/23/2026

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: 383532
• Device Lot Number: 5239531
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/09/2026; 02/23/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 02/10/2026; 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown