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

Catalog Number 383517

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

It was reported that 5 of the bd nexiva¿ iv catheter jams the needle slide and the metal sounds, then triggers forward.The following information was provided by the initial reporter, translated from spanish to english: the leader reports the same previous case that it jams to push the needle slide and the metal sounds, then triggers forward, until now without harm to the patient or user.

Manufacturer Narrative

Initial reporter phone #: (b)(6).Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the photographs submitted for evaluation.Bd received two photographs which displayed a 20g nexiva device in opened packaging without the needle cover.The needle was positioned within the catheter.The grip was attached to the tip shield and the tip shield was attached to the catheter adapter.The device appeared to be unused.The second photo showed the label with reference number 383517, lot number 2122704.Since the functionality of the device could not be represented in the photograph, the reported issue could not be confirmed.

Event Description

It was reported that 2 of the bd nexiva¿ iv catheter cannot detach.The following information was provided by the initial reporter, translated from spanish to english: one of them cannot be detached, they already threw me away, but it is the same problem, i have one and i want to see if you can replace it, please, i have the unit in the emergency room.

• Brand Name: BD NEXIVA¿ IV CATHETER
• 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: 16211982
• MDR Text Key: 308772581
• Report Number: 1710034-2023-00019
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835171
• UDI-Public: 00382903835171
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383517
• Device Lot Number: 2122704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2022
• 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