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

Catalog Number	383552
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd nexiva sp with maxzero tubing separated from adapter.The following information was provided by the initial reporter: a pipe came loose while it was attached to a patient.Fortunately, a nurse was nearby, and it ended well.However, can you have a check if this was an isolated case, or if there could have been a manufacturing defect somewhere? was patient or user harmed? no, not in the end.Because a nurse was nearby in time, she was able to resolve the problem.
Additional Manufacturer Narrative
In response to the event reported by your facility a device history review was conducted for lot number 4242265.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally a sample was returned to aid in our investigation.The returned unit arrived with the tubing separated from the main housing; microscopic inspection of the tubing inlet was unable to identify the presence of any tubing fragments, which would suggest the application of excess tensile force to the tubing.Uv lights were also used to look for the presence of the uv-sensitive adhesive in the inlet; none was observed.Based on the these observations our engineers were able to associate the root cause for this event with the manufacturing process.Adhesive application is an automated process and likely resulted from abnormal variation in the air pressure of the dispensing system.Nonconformances of this nature are currently monitored through the complete inspection of all finished goods.
Event or Problem Description
No additional infromation.

• Brand Name: BD NEXIVA SP WITH MAXZERO
• 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: 22119561
• Report Number: 1710034-2025-00928
• Device Sequence Number: 4122470
• Product Code: FOZ
• UDI-Device Identifier: 00382903835522
• UDI-Public: (01)00382903835522(10)42422585
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 07/23/2025

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: 383552
• Device Lot Number: 4242265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown