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	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva sp with maxzero catheter releases prematurely.The following information was provided by the initial reporter: during the placement of a peripheral infusion, the catheter detached from the needle without any traction being exerted.Could you please provide more detail about the event, what was the exact issue? catheter came loose from needle.Was there any patient or user impact? needle was inserted in patient.
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.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
Additional information in b tab.Investigation results: the complaint that the extension tubing detached from the catheter adapter was confirmed and the cause appeared to be manufacturing related.One 22g nexiva device was returned for investigation.The extension tubing completely separated from the catheter adapter.It appeared that the tubing was not properly bonded to the catheter adapter.The appropriate manufacturing personnel were notified of this complaint.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.
Event or Problem Description
Additional information 1.Could you please confirm the statement "3x happened at 1.5 months" are these 3 occurrences over 1.5 months or is 3 occurrences on a 1.5-month-old patient.= three occurrences over 1,5 months.

• 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: 22330555
• Report Number: 1710034-2025-01084
• Device Sequence Number: 8411051
• Product Code: FOZ
• UDI-Device Identifier: 00382903835522
• UDI-Public: (01)00382903835522(11)240830(17)270831(10)4242265
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/15/2025
• 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