Model Number IPN028454 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2021 |
Event Type
Injury
|
Event Description
|
Medwatch # (b)(4).Large pneumothorax noted on routine morning chest x-ray.Determined to be caused by an air leak in the pleur-evac.Patient was not in distress but did have some pain and coughing.Air leak fixed and lung re-expanded.
|
|
Manufacturer Narrative
|
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
|
|
Event Description
|
Medwatch #(b)(4).Large pneumothorax noted on routine morning chest x-ray.Determined to be caused by an air leak in the pleur-evac.Patient was not in distress but did have some pain and coughing.Air leak fixed and lung re-expanded.
|
|
Manufacturer Narrative
|
(b)(4).A dhr review could not be conducted since the lot number was not provided.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the root cause and the corresponding corrective actions.Customer complaint cannot be confirmed due the lack of defective sample to perform a proper investigation and determine the root cause.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.
|
|
Search Alerts/Recalls
|