MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 20 GA X 1 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383516

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 01/21/2024

Event Type  malfunction  

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

It was reported that bd nexiva 20 ga x 1 in single port experienced difficulty withdrawing the needle.The following information was provided by the initial reporter, translated from chinese to english: a situation where a healthcare professional finds it impossible to withdraw the needle core tip after puncturing a patient.

Manufacturer Narrative

Investigation results: received one unsealed 20ga x 1.00in.Nexiva unit.Additionally, one photo was provided.During investigation it was confirmed that the adapter was unable to be removed from the tip shield.After forcefully decoupling the device, damage to the inside of the tip shield was discovered.It was also noticed that the v clip was not disengaging fully so it was not removing the adapter after disengaging the needle.The reported defect was confirmed.The damage inside the tip shield also resembles a manufacturing defect due to misalignment while inserting the needle into the grip and tip shield.Operators perform in process sampling and testing for retraction to mitigate the risk from this type of defect.Preventative maintenance (pm's) are also performed periodically to ensure proper functioning of the equipment.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Investigation conclusion(s): the defect of ¿failure to decouple¿ was confirmed.Probable root cause(s): manufacturing.The appropriate manufacturing personnel were notified of this complaint.

Event Description

No additional information.

• Brand Name: BD NEXIVA 20 GA X 1 IN SINGLE PORT
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18627380
• MDR Text Key: 334627855
• Report Number: 1710034-2024-00061
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903835165
• UDI-Public: (01)30382903835165
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

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: 383516
• Device Lot Number: 3072352
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1