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

Catalog Number 383519

Device Problem Fluid/Blood Leak (1250)

Patient Problem Extravasation (1842)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that bd nexiva leaked past the septum during iv insertion.The following information was provided by the initial reporter: i have another defective iv in my office.A nurse was placing an 18ga nexiva 1.25in iv catheter in a patient when the butterfly portion of the iv started pouring blood.This occurred after the needle portion had been removed.

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.

Event Description

No additional information.

Manufacturer Narrative

Investigation results: received one used catheter assembly of an 18gx1.25in nexiva device single port from lot 3059789 for the investigation of this complaint.A gross visual inspection shows there is blood beyond the canister and primary second appear damage.These damages are evidence to the leakage that was reported by the customer.Microscopic inspection of the device revealed that the primary septum was seated correctly on the canister.The canister and primary septum were removed from the winged adapter to allow for a clear inspection of the components.Removing the canister showed that the primary septum is seated correctly though a space between the canister and the septum can be observed.The space is created by a damage at the lip of the septum.A damage that certainly allowed the blood to leak.The type of damage to the canister as seen on this unit may occur during manufacturing while assembling the canister and septum together or when inserting the canister/septum assembly into the winged adapter due to misalignment or damaged tooling/grippers.During manufacturing, operators perform leak testing and inspections for damaged components per the sampling and quality control plan to mitigate the occurrence of this defect.The appropriate manufacturing personnel were notified of this complaint.The dhr for lot 3059789 has been reviewed.No related quality issues or process deviations were found.Investigation conclusion(s): the defect of ¿leakage at septum¿ was confirmed.Probable root cause: manufacturing.

• 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: 18360862
• MDR Text Key: 331296122
• Report Number: 1710034-2023-01456
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835196
• UDI-Public: (01)30382903835196
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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: 383519
• Device Lot Number: 3059789
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/22/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1