MAUDE Adverse Event Report: NEXIVA 22GA 1.00IN Y; INTRAVASCULAR CATHETER

Catalog Number 383532

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

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 nexiva 22ga 1.00in y was expired.The following information was provided by the initial reporter: customer called to advise that she is a nurse and has used a bd nexiva device on a patient with an expired date.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 7332592.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately, a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.H3 other text : see h.10.

Event Description

It was reported that nexiva 22ga 1.00in y was expired.The following information was provided by the initial reporter: customer called to advise that she is a nurse and has used a bd nexiva device on a patient with an expired date.

• Brand Name: NEXIVA 22GA 1.00IN Y
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12047010
• MDR Text Key: 260828031
• Report Number: 1710034-2021-00524
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835324
• UDI-Public: 00382903835324
• Combination Product (y/n): N
• PMA/PMN Number: K183399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 383532
• Device Lot Number: 7332592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2017
• 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