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

Catalog Number	383557
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562); Free or Unrestricted Flow (2945)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that bd nexiva sp with maxzero tubing partially separated from hub; leaked and drew air during lab draw.The following information was provided by the initial reporter: nurse inserted iv and immediately afterward went to draw bloodwork.Noted that ++ air was being siphoned.Assessed iv catheter system and noted that the area between the distal pink hub and tubing was partially disconnected and leaking blood.Delay in patient case removed and new iv inserted (additional cost).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Patient codes updated: investigation results: the complaint that the extension tube was partially disconnected from the pink hub was confirmed from the photograph that was provided for investigation.The photograph showed a 20g nexiva iv catheter.The needle had been removed from the catheter and the device exhibited evidence of use.What appeared to be blood residue was observed within the extension tubing and catheter tubing.What was consistent with air bubbles was observed in the extension tubing, which would be a concomitant issue from the partially separated extension tube.The extension tubing was positioned within the pink luer adapter but was not aligned with the axis of the adapter.It appeared that the tubing was partially separated from the adapter.Due to the condition of the sample, the root cause of the reported issue could not be determined from the photograph.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.A review of manufacturing records was performed and there were no issues during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• 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: 21690477
• Report Number: 1710034-2025-00476
• Device Sequence Number: 8849723
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577(11)240730(17)270731(10)4212448
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

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: 383557
• Device Lot Number: 4212448
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown