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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
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 was not seated properly in hub.The following information was provided by the initial reporter: (b)(6) has received the following product complaint from our customer regarding a product purchased from your company.Please provide us with a written acknowledgment to this report advising us of your complaint reference number within 10 business days.* please provide your investigation results and corrective actions within 90 days of this notice* to ensure compliance with our medical device regulations which are governed by (b)(6).The following are all the available complaint details now: complaint category: fail to function / defective.Incident date: (b)(6) 2025.Details of complaint (reported issue): the tube was not fully seated to the port so once the iv was started it malfunctioned.Occurred on (b)(6), 2025.Please contact (b)(6) at (b)(6) if you have any specific questions regarding this complaint.Complaint noticed: during / after use.Problem frequency: 1st time.Patient injury: no.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: the complaint of detached extension tubing was confirmed, and the cause appeared to be manufacturing related.One 22ga nexiva unit from lot: 4242265 was provided for investigation.The tip of the extension tubing was not positioned within the catheter adapter.Instead, the external surface of the tubing was bonded with adhesive to the external surface of the catheter adapter, allowing fluid to leak.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.

• 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: 21462121
• Report Number: 1710034-2025-00310
• Device Sequence Number: 12809152
• 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: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 02/11/2025
• Supplement Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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