EQUASHIELD 20 ML MILLILITRE(S)
Received Mar 9, 2026 · Event occurred Mar 3, 2026
Report MW5184914 · MDR key 24547786
Device
Generic name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medic
Manufacturer
Equashield LlcPatient
63 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
WHILE ADMINISTERING DARZALEX FASPRO TO A PATIENT, THE CLOSED SYSTEM TRANSFER DEVICE SYRINGE MALFUNCTIONED, CAUSING THE DRUG TO BACKFLOW PAST THE RUBBER SYRINGE AND INTO THE SYRINGE INSTEAD OF BEING ADMINISTERED TO THE PATIENT. THE DOCTOR WAS NOTIFIED AND AFTER CONSULTING WITH CHEMOTHERAPY PHARMACISTS WAS REASONABLY SURE THAT ONLY A MINIMUM AMOUNT OF THE DRUG WAS POSSIBLY GIVEN TO THE PATIENT AND THE DOSE WAS REMADE AND GIVEN WITH NO ISSUES. AS THE DOSE WAS PREPARED AND SENT TO ONCOLOGY AT THE END OF THE COMPOUNDING DAY, THE TRASH HAD ALREADY BEEN REMOVED FROM THE COMPOUNDING AREA AND THE LOT NUMBER OF THE AFFECTED SYRINGE IS NOT KNOWN.