Catalog Number AK-21242-X |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/08/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported "raulerson syringe not holding negative pressure." clarification to event was received by complainant and stated "when you pull back on the raulerson syringe it leaks air and doesn't hold vacuum pressure." no medical intervention required.Patient condition reported as "fine".
|
|
Event Description
|
It was reported "raulerson syringe not holding negative pressure." clarification to event was received by complainant and stated "when you pull back on the raulerson syringe it leaks air and doesn't hold vacuum pressure." no medical intervention required.Patient condition reported as "fine".
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
|
|
Search Alerts/Recalls
|