inforMED
MalfunctionKYZ

MONOJECT

Received Jun 12, 2026 · Event occurred Apr 20, 2026

Report 25484929 · MDR key 25484929

Device

Generic name

Syringe, Irrigating (non Dental)

Model number

460SG

Catalog number

460SG

Lot number

CN250901

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

60 CC MONOJECT ENTERAL SYRINGE FOUND DEFECTIVE. FEED DRAWN UP IN 60 CC SYRINGE, ATTACHED FEED TUBING AND PRIMED THROUGH TUBING WITH DIFFICULTY AND RESISTANCE MET. AFTER TUBING PRIMED ATTACHED TO PATIENT AND FEED PROGRAMMED INTO PUMP. A FEW MINUTES AFTER STARTING, THE PUMP ALARMED WITH "OCCLUSION". SYRINGE DISCONNECTED AND ANOTHER SYRINGE USED TO DRAW BACK AND PUSH SMALL AMOUNT OF AIR THROUGH TUBING AND NG [NASOGASTRIC] TUBE, NO RESISTANCE MET. WHEN MOVING PLUNGER OF 60 CC SYRINGE, RESISTANCE MET. FOR THIS FEED, REPLACED SYRINGE WITH BD SYRINGE AND FEED ATTACHMENT. THIS EVENT OCCURRED FOR TWICE DURING THE FIRST AND SECOND CARE TIMES. USED 35 CC SYRINGES FOR REMAINDER OF SHIFT. ASKED AROUND ON THE UNIT AND FOUND MANY NURSES WHO HAD SIMILAR PROBLEMS WHEN MOVING PLUNGER OF 60 CC SYRINGES. MANUFACTURER RESPONSE FOR 60ML ENTERAL SYRINGE, 60ML MONOJECT ENTERAL SYRINGE (PER SITE REPORTER). EMAILED MANUFACTURER TO RETURN THE PRODUCT ON [REDACTED].