Catalog Number 383536 |
Device Problem
Separation Problem (4043)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
|
|
Event Description
|
It was reported that bd nexiva did not completely disengage from the catheter.The following information was provided by the initial reporter: rn was starting an iv on an or patient retracted the needle prior to insertion to ensure the catheter was intact, per manufacturer recommendation.She followed iv insertion protocol, got sufficient blood return from the patient and as she went to advance the catheter the needle got stuck retracting about halfway.The needle would no longer advance or retract completely, and she had to remove the iv completely.On inspection, the needle was in fact stuck halfway in the catheter and would not advance or retract.The iv was discarded in the sharps box.
|
|
Manufacturer Narrative
|
A device history record review was completed by our quality engineer team for provided material number 383536 and lot number 3268510.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
|
|
Search Alerts/Recalls
|
|