MalfunctionKYX
MINI SPIKE I.V. DISPENSING PIN
Received Dec 12, 2023
Report MW5149188 · MDR key 18319244
Device
Patient
Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
SPONTANEOUS. PATIENT REPORTED THAT THEY SPIKE GAMMAGARD LIQUID VIAL WITH MINISPIKE AND TRIED TO TRANSFER MED TO SYRINGE, BUT MED IS NOT STAYING IN THE SYRINGE; IT'S GOING BACK INTO THE VIAL. RPH(REGISTERED PHARMACIST) INFORMED PT TO TRY ANOTHER MINISPIKE AND SYRINGE. PT CONFIRMED USING A DIFFERENT MINISPIKE WORKED. UNKNOWN IF PATIENT MISSED A DOSE, EXPERIENCED AN ADVERSE EVENT, OR IF DEFECTIVE DEVICE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION. REPORTED TO (B)(6) BY PT/CAREGIVER.