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

Catalog Number 383516

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd nexiva needle felt rough during disengagement.The following information was provided by the initial reporter: when withdrawing the needle from the catheter, it felt very 'rough' coming out.Not sure if this has anything to do with some of other issues we've been experiencing (needle not disengaging, frayed catheters).

• 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: 18243356
• MDR Text Key: 329448024
• Report Number: 1710034-2023-01369
• 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: 11/13/2023

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: Health Professional
• Device Catalogue Number: 383516
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/30/2023
• 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