MalfunctionFMF
TAK-999 NSD+PFS
Received Jul 16, 2026 · Event occurred Jun 16, 2026
Report 2032282-2026-00132 · MDR key 25849525
Device
Generic name
Syringe
Manufacturer
Takeda Pharmaceuticals U.s.a, Inc.Product problems
- Mechanical Jam
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SAMPLE IS REQUESTED FOR FURTHER INFORMATION.
Description of Event or Problem
AT THE END OF INJECTION PROCESS, THE NEEDLE DID NOT RETRACT. AFTER MANIPULATION OF THE SYRINGE AFTER THE PROCESS, THE NEEDLE RETRACTED. WE DID NOT TAKE ANY PICTURES OF THE MATERIAL AT THE TIME, AS WE DIDN'T HAVE THIS FORM AT THE TIME AND WERE NOT AWARE OF THE NECESSITY OF PHOTOS.