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

Catalog Number	383511
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
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 single port clamp broke.The following information was provided by the initial reporter: white clamp broke while on the patient.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a broken clamp was confirmed; however, the root cause could not be determined.Two photographs were provided for investigation.One photograph showed a fractured clamp on a 24g nexiva device.The nexiva was shown inserted in a patient and dressed.The cause of the damage to the clamp could not be determined from the photographs.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.No other similar complaints were reported from the implicated lot.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.

• 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: 22500379
• Report Number: 1710034-2025-01179
• Device Sequence Number: 7029385
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)250328(17)280331(10)5087858
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 383511
• Device Lot Number: 5087858
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown