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

Catalog Number 383557

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2024

Event Type  malfunction  

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 Description

It was reported that bd nexiva sp with maxzero needle did not disengage.The following information was provided by the initial reporter: failed nexiva device this evening at brownsburg.The needle would not retract in order to advance the catheter.All connections were loosened prior to placement.Iv had to be removed.They disposed of the needle.Patient got a new iv.

• Brand Name: BD NEXIVA SP WITH MAXZERO
• 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: 19203601
• MDR Text Key: 341729857
• Report Number: 1710034-2024-00370
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835577
• UDI-Public: (01)00382903835577
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

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: 383557
• Device Lot Number: 3354896
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1