MAUDE Adverse Event Report: BECTON DICKINSON BD NEXIVA 20GA 1.25IN HF Y; INTRAVASCULAR CATHETER

Catalog Number 383537

Device Problem Fitting Problem (2183)

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

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd nexiva 20ga 1.25in hf y luer fittings incompatible the following information was provided by the initial reporter: hereby i would like to inform you of a complaint regarding needle iv nexiva dual port 20gx32mm.Description of complaint: after insertion of needle, the q-site provided with the needle cannot be turned on the port.The split septum is not passable to barrel through.The q-site does not fit on the system.We have received several complaints about this from the same lot number.The item including packaging is in our possession.Should it be required for examination, please inform me.

• Brand Name: BD NEXIVA 20GA 1.25IN HF Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18565265
• MDR Text Key: 333501705
• Report Number: 2243072-2024-00054
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835370
• UDI-Public: (01)30382903835370
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2024

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: Other
• Device Catalogue Number: 383537
• Device Lot Number: 3149861
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1