Catalog Number 383914 |
Device Problem
Difficult or Delayed Activation (2577)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/18/2020 |
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.(b)(4).
|
|
Event Description
|
It was reported that pegasus yel 24ga x 0.75in qsyte-cap y needle was getting stuck while removing.This occurred on 12 occasions during use.The following information was provided by the initial reporter: after puncturing, the removement of the needle was getting stuck, which was also difficult, it caused failure puncturing.
|
|
Manufacturer Narrative
|
Investigation summary a device history review was conducted for lot number 9168746.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.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.
|
|
Event Description
|
It was reported that pegasus yel 24ga x 0.75in qsyte-cap y needle was getting stuck while removing.This occurred on 12 occasions during use.The following information was provided by the initial reporter: after puncturing, the removement of the needle was getting stuck, which was also difficult, it caused failure puncturing.
|
|
Search Alerts/Recalls
|