MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA SINGLE PORT; 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	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva single port iv broke from above the hub.The following information was provided by the initial reporter: patient was receiving iv steroid and was playing with iv.Iv broke from above the hub on the line.The yellow connector as well as the blue hub was attached to the line.Line was open in patient's arm.Line given to educator.Impact of incident: delay to treatment/therapy.
Additional Manufacturer Narrative
Delay in treatment is stated.Restarting an iv typically poses a nominal delay and does not indicate that a serious injury has occurred.Follow up questions to customer in progress to clarify patient outcome.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
Additional information related to patient outcome.See: describe event or problem.Annex f codes updated.
Event or Problem Description
1.Yes, the treatment was completed with a delay.2.No harm to the patient was detected.3.New piv initiated and new dose of the medication acquired from pharmacy, which was then completed.
Additional Manufacturer Narrative
Investigation results: the complaint of a break in the tubing was confirmed.However, the root cause could not be determined.The yellow luer adapter from a 24g nexiva device was received with an extension set.The remainder of the nexiva device was not provided for investigation.The extension tubing of the nexiva device completely broke at the distal end of the luer adapter.A piece of tubing remained adhered within the luer adapter.It appeared that the tubing was properly bonded to the luer adapter.Due to the evidence of use, the break likely occurred after insertion.However, the root cause could not be determined.No damage associated with the manufacturing process was identified on the returned sample.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 additional information.

• Brand Name: BD NEXIVA SINGLE PORT
• 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: 21855900
• Report Number: 1710034-2025-00606
• Device Sequence Number: 7916744
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)250103(17)271231(10)5003775
• 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: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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: 5003775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: Not provided; 05/09/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 04/28/2025; 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown