Catalog Number 383712 |
Device Problem
Material Deformation (2976)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/03/2021 |
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 pegasus yel 24ga x 0.75in prn-cap y tubing clamp was loose.This occurred on 5 occasions.The following information was provided by the initial reporter: in the emergency department, when after injection, the blood is returned to the prn after the pinch clamp is closed.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-07.H6: investigation summary: a device history review was conducted for lot number 0272320.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.Additionally, a sample was obtained for evaluation and testing.During visual analysis of the device, our engineers noted that the clamp was not fully activated.Our engineer were able to fully activate the clamp without the application of excess force; subsequent occlusion testing of the device was unable to return blood in the same manner as the initial complaint.Based on the available observations our engineers were not able to associate this non-conformance with the manufacturing process.
|
|
Event Description
|
It was reported that pegasus yel 24ga x 0.75in prn-cap y tubing clamp was loose.This occurred on 5 occasions.The following information was provided by the initial reporter: in the emergency department, when after injection, the blood is returned to the prn after the pinch clamp is closed.
|
|
Search Alerts/Recalls
|