MAUDE Adverse Event Report: NEXIVA 24 GA X 3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number 383511

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/30/2021

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 24 ga x 3/4 in single port needle was loose.This occurred on 6 occasions.The following information was provided by the initial reporter: it happened in the transfusion room of pediatric outpatient department.When nurse opened the indwelling needle, the needle became loose and felt very astringent.It was suspected that there were impurities or rust inside.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the physical sample returned for evaluation.Bd received one sample for this incident.Upon initial visual inspection of the unit, no damages or defects to the device could be found.The washer component was further inspected and was unable to move, which is an indicator of difficult disengagement.While retracting the needle, difficulty was confirmed.The needle continuously caught against the washer component, preventing disengagement.The needle was removed from the device and it was observed that the washer component was lodged into the tip shield.Upon removal of the tip shield, the washer component was observed stuck in the tip shield at an angle.This type of damage would result within the manufacturing process.To mitigate the occurrence of this defect, in-process sampling is performed by operators as well as preventative maintenance to ensure proper functioning of the equipment.The preventative maintenance records were inspected and verified that everything was up to date during the manufacture of this lot.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.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that nexiva 24 ga x 3/4 in single port needle was loose.This occurred on 6 occasions.The following information was provided by the initial reporter: it happened in the transfusion room of pediatric outpatient department.When nurse opened the indwelling needle, the needle became loose and felt very astringent.It was suspected that there were impurities or rust inside.

• Brand Name: NEXIVA 24 GA X 3/4 IN SINGLE PORT
• Type of Device: INTRAVASCULAR CATHETER
• MDR Report Key: 12021640
• MDR Text Key: 260760619
• Report Number: 1710034-2021-00508
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: 00382903835119
• 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: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 383511
• Device Lot Number: 0163980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• 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