Model Number 18320 |
Device Problem
Retraction Problem (1536)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/31/2023 |
Event Type
malfunction
|
Event Description
|
It was reported via social media that a patient's needle mechanism did not fully retract as intended during activation.
|
|
Manufacturer Narrative
|
According to the complainant the device will not be returned for investigation.We are unable to confirm the reported needle mechanism failure or to determine its root cause.Lot release records were reviewed and the product lot met all acceptance criteria.Specifically, a pod is paired to a pdm and put through simulated use testing including confirming that the device deployed the cannula correctly.
|
|
Manufacturer Narrative
|
The device was received partially deployed with the needle exposed beyond the needle well.The downloaded data did not show any timeouts or drive stalls during its run.Score marks were observed on the interior of the top housing, indicating an interference between the linkage assembly and top housing.The needle mechanism was reset to the not deployed position and deployed as intended through manual advancement of the ratchet gear.Thus, the misaligned linkage assembly caused the needle to not retract.
|
|
Search Alerts/Recalls
|