Catalog Number 401622 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/29/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: received a notice from teacher of the anesthesiology department, the complaint was mainly about the leakage of low-resistance syringes during use (the lumbar anaesthesia needle and syringes are often not connected closely, so there is complete leakage of air, and no resistance can be detected).
|
|
Manufacturer Narrative
|
H.6.Investigation: a device history review was conducted for lot number 0311824.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, visual analysis was performed on retention samples for this lot, the retained devices were found to be free of any damage or other abnormalities.Unfortunately 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 the anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: received a notice from teacher of the anesthesiology department, the complaint was mainly about the leakage of low-resistance syringes during use (the lumbar anaesthesia needle and syringes are often not connected closely, so there is complete leakage of air, and no resistance can be detected).
|
|
Search Alerts/Recalls
|