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

Catalog Number	383537
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When did the incident occur? during use.Hub of the nexiva fractures during use, not yet known what medication and how it was used.(b)(6).Was patient or user harmed? if yes, please explain no, but treatment was disrupted.Was additional medical intervention/medication required? if yes, please explain no.If leakage occurred, please confirm the fluid that leaked.Perfan.Its active ingredient is enoximone, a phosphodiesterase iii inhibitor with positive inotropic and vasodilatory effects.Could you please confirm what medication was used and how it was used.Perfan.Its active ingredient is enoximone, a phosphodiesterase iii inhibitor with positive inotropic and vasodilatory effects.10mg/ml solution.
Additional Manufacturer Narrative
As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Additional Manufacturer Narrative
C code correction.
Additional Manufacturer Narrative
The complaint of a crack in the pink dual port luer adapter was confirmed.The cause may have been a combination of various circumstances; however, manufacturing was likely a contributing factor.One 20g nexiva iv catheter was provided for investigation.The sample exhibited evidence of use.A longitudinal crack was identified on one of the pink luer adapters.While overtightening at the connection may have been a contributing factor, the material typically will not crack.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.
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: 23476631
• Report Number: 1710034-2025-01726
• Device Sequence Number: 18749707
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K183399
• 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,Followup
• Report Date (Section B): 01/30/2026

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: 383537
• Device Lot Number: UNKNOWN
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/28/2026; Not provided
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 01/28/2026; 01/30/2026
• 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