inforMED
MalfunctionKYX

MINI SPIKE I.V. DISPENSING PIN

Received Dec 12, 2023

Report MW5149188 · MDR key 18319244

Device

Generic name

Dispenser, Liquid Medication

Lot number

P100014491

Patient

Female

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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.