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

Catalog Number 383537

Device Problem Separation Problem (4043)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Event Description

It was reported that bd nexiva needle disengagement is difficult.The following information was provided by the initial reporter translated from dutch to english: when we puncture and we remove the needle, sometimes blood leaks during blood collection from the gray eraser along which the needle is removed (see photo).The needle sometimes sticks to the eraser and so we don't get it completely removed.When injecting, the fluid or medication also gets past the eraser.As a result, patient had to be re-pricked to have safe medication access and avoid infection risk.Can this be included with bd supplying these catheters? so, should we not use this alternative anyway or should we stand by and list how frequently it occurs? or have there been any reports? these three problems occurred at many intervals (one as recently as december, one a week ago, one today) but it may also have often gone unreported or gotten to us.When we puncture and we remove the needle, sometimes blood leaks during blood collection from the gray eraser along which the needle is removed (see photo).The needle sometimes sticks to the eraser and so we don't get it completely removed.When injecting, the fluid or medication also gets past the eraser.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.3 total occurrences for this failure described.1 with known event date and and patient outcome information.Two without known event date and no patient outcome information provided.

• 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: 18826785
• MDR Text Key: 337702169
• Report Number: 1710034-2024-00154
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835370
• UDI-Public: (01)30382903835370
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K102520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2024

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: 383537
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/04/2024
• 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