MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR CATHETER

Model Number 383558

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nexiva¿ single-port with maxzero¿ needle-free connector experienced difficulty with the needle disengaging.The following information was provided by the initial reporter: they couldn't get the needle inside the nexiva catheter out after placing the device.

Event Description

It was reported that the bd nexiva¿ single-port with maxzero¿ needle-free connector experienced difficulty with the needle disengaging.The following information was provided by the initial reporter: they couldn't get the needle inside the nexiva catheter out after placing the device.

Manufacturer Narrative

H6: investigation summary : there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

• Brand Name: BD NEXIVA¿ SINGLE-PORT WITH MAXZERO¿ NEEDLE-FREE CONNECTOR
• Type of Device: INTRAVASCULAR CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16383847
• MDR Text Key: 309642655
• Report Number: 1710034-2023-00112
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835585
• UDI-Public: (01)30382903835585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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 Model Number: 383558
• Device Catalogue Number: 383558
• Device Lot Number: 2308968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1