MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD NEXIVA 22 GA X 1 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383512

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

B3.The date received by manufacturer has been used for this field.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 four bd nexiva 22 ga x 1 in single port were difficult to disengage.The following information was provided by the initial reporter: i wanted to inform you of a few incidents we had this week with 22ga x 1.00in nexiva's, after successfully inserting the catheter into the patient and retracting the needle into the gray safety shield, the gray safety shield would not disengage from the self-sealing diaphragm.Therefore, the catheter had to be removed from the patient and the patient had to be re-stuck.Upon visual inspection of the gray safety shield, the plastic did not appear smooth as it normally does.This has occurred four times, three of which patients had to be re-stuck.In the other incident, the needle eventually was removed with much manipulation.

Manufacturer Narrative

Not being able to disconnect the tubing from the hub may lead to customer dissatisfaction or patient inconvenience as a new iv insertion may be required but does not lead to harm / serious injury.This event is not mdr reportable.

Event Description

Na.

• Brand Name: BD NEXIVA 22 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: 18637117
• MDR Text Key: 334846648
• Report Number: 1710034-2024-00064
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: Other
• Device Catalogue Number: 383512
• Device Lot Number: 3244628
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2024
• Initial Date FDA Received: 02/03/2024
• Supplement Dates Manufacturer Received: 01/20/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1