MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA¿ CLOSED IV CATHETER SYSTEM; INTRAVENOUS CATHETER

Model Number 383511

Device Problem Retraction Problem (1536)

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

Event Date 09/23/2022

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 2 bd nexiva¿ closed iv catheter system failed to separate from catheter.The following information was provided by the initial reporter, translated from japanese to english: the needle was not separated from the catheter.

Manufacturer Narrative

H6: investigation summary our quality engineer inspected the samples and photographs submitted for evaluation.Bd received two retracted but not decoupled nexiva 24g x 0.75in units from lot 2091312.In addition, six photographs were submitted which displayed two units with sign of usage and the tip shield still attached to the adapter.The photographs displayed similarities to the returned units.Through the visual inspection of the units, we confirmed that the device is unable to decouple.The needles are fully retracted, and the tip shields have not separated from the winged adapter.When attempting to separate the adapter and tip shield it was noticed that the components could rotate removing adhesive as a potential cause.Once the two components were separated it was observed that the back of the catheter adapter is damaged on both components.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to a misalignment of the part or tooling.Operators perform in process inspections and function testing per our quality plan.Additionally, preventative maintenance (pm) is performed per the quality plan to ensure proper alignment and functioning of the equipment.The pm records were verified to be up to date during the manufacturing of this lot.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that 2 bd nexiva¿ closed iv catheter system failed to separate from catheter.The following information was provided by the initial reporter, translated from japanese to english: the needle was not separated from the catheter.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVENOUS 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: 15651515
• MDR Text Key: 306811640
• Report Number: 1710034-2022-00613
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835110
• UDI-Public: (01)30382903835110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383511
• Device Catalogue Number: 383511
• Device Lot Number: 2091312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1