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

Catalog Number	383538
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K183399; k243403.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.
Event or Problem Description
It was reported that the tubing leaked at the adapter-tubing junction."it was reported that today ultrasound guided iv was inserted in the above patient.The iv was correctly placed, but after placing the iv the iv system turned out to be leaky.Blood leaks up the end of the tube, just below the junction where fluids can be administered." "the risk for the patient is that the chance of a running iv is smaller, because these patients had already been pricked with the ultrasound and if the leakage were not seen, medication would not reach the patient.".
Additional Manufacturer Narrative
The complaint of a leak was confirmed; however, the root cause could not be determined.One photograph was provided for investigation, which showed one 20g nexiva iv catheter with evidence of use.What appeared to be blood residue was observed throughout the catheter tubing and extension tubing.The vent plug remained attached to the pink dual port luer adapter.What appeared to be blood residue was observed on the external surface of the dual port adapter, which supports that complainant¿s description of a leak.The distal end of the dual port luer adapter and the proximal end of the tubing were circled; however, the details and characteristics of the leak path could not be observed from the photograph.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 our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
Event or Problem Description
No new information.

• 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: 25145224
• Report Number: 1710034-2026-00503
• Device Sequence Number: 21521857
• Product Code: FOZ
• UDI-Device Identifier: 00382903835386
• UDI-Public: (01)00382903835386
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 383538
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown