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

Catalog Number	383512
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that nexiva tubing had a hole."piv catheter set- rn went to stick the patient, when in the vein and attempting to flush, tubing noted to have a hole.Piv removed.And new piv set obtained and piv placed without issue.¿ additional information 3/16/2026: no serious injury occurred to the patient.When iv was noted to be leaking/have a hole, it was removed.The patient was stuck again with a working iv.The only result was the patient needed to be stuck twice.
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
No additional information.
Additional Manufacturer Narrative
Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of tubing defective / damaged with lot 5301041 regarding item #383512.Dhr was reviewed for all reports of defects.No related quality issues or process deviations were found.A review of the applicable risk documents indicate that the potential risk of the reported event was assessed appropriately in the risk management documentation.

• Brand Name: NEXIVA
• 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: 24625985
• Report Number: 1710034-2026-00286
• Device Sequence Number: 21099487
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: (01)00382903835126(11)251028(17)281031(10)5301041
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 383512
• Device Lot Number: 5301041
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown