Device Problems
Difficult to Remove (1528); Use of Device Problem (1670)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2020
Event Type
malfunction
Event Description
Single use caps on prefilled syringes can be removed without breaking them as designed allowing the cap to be reused.The syringe contents can be adulterated or diverted without detection.Fda safety report id# (b)(4).