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

Catalog Number 383516

Device Problem Stretched (1601)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva ballooned.The following information was provided by the initial reporter: new nexvia iv catheters in circulation.20g iv in the right ac used for ct of the abdomen with contrast.Per ct tech she was using 1/2 the pressure rate and the contrast was connected to the hub closest to the patient.This has been difficult with the new iv catheters as there is only a single lumen.Pt was positioned as normal, pressure as normal, scan ran as normal.When tubing was checked, the pressure had blown the iv tubing up past where it was clamped.Contrast did not reach the patient.Pt had to be rescanned with contrast, therefore recieved double the dose of radiation.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.

• Brand Name: BD NEXIVA
• Type of Device: 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: 18108255
• MDR Text Key: 328642112
• Report Number: 1710034-2023-01283
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: (01)30382903835165
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Operator: Other
• Device Catalogue Number: 383516
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1