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

Catalog Number	383557
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
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 leaked.The following information was provided by the initial reporter: date of incident: on (b)(6) 2025 concern description: blood leaking from tubing once inserted into patient vein (possible puncture in tubing or hole).Customer responded on (b)(6).Patient required a second inserted piv as a result of faulty nexiva piv catheter.
Additional Manufacturer Narrative
In response to the event reported by your facility, a device history review (dhr) was conducted for lot number 4248809 and material 383557.No related quality issues or process deviations were identified during the review.Two nexiva units were provided for to aid in our investigation, and functional testing confirmed a leak in the extension tubing of the used iv catheter.A semi-circumferential breach was observed, which may have been associated with clamping; however, due to the device being opened and used, it could not be determined whether the damage occurred during manufacturing or use.As a result, the root cause could not be confirmed.
Event or Problem Description
No additional information.

• 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: 22107223
• Report Number: 1710034-2025-00914
• Device Sequence Number: 15507776
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577(11)240904(17)270831(10)4248809
• 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: User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

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: 4248809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown