|
Device Problems
Product Quality Problem (1506); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/04/2022 |
Event Type
malfunction
|
Event Description
|
End user reported that the plunger in the syringes were difficult to move up and down and seemed dry, lacking silicon while using insulin syringes.The syringes the user is reporting issues with are item number 829155; lot number 50273, expiration date 8/29/2024 and also item number 830355; lot number 54487 expiration date 6/29/2026.The end user also reports while using the same lot number syringes that the needled feel dull when penetrating the skin.
|
|
Manufacturer Narrative
|
Initial trend analysis for lots 50273 and 54487 were conducted, no malfunctions were found.This is the only complaint for lots 50273 and 54487.Further investigation will be conducted to determine the root cause of complaint.
|
|
Search Alerts/Recalls
|
|
|