RELIZORB
Received Aug 28, 2025 · Event occurred Aug 22, 2025
Report MW5175329 · MDR key 22913325
Device
Product problems
- Crack
- Fluid/Blood Leak
- Material Separation
- Device Dislodged or Dislocated
Patient
5 YR · Male
- Hypoglycemia
- Hypoglycemia
Narrative
Description of Event or Problem
AT AROUND 0200 PATIENT DEXCOM WAS READING DECREASED BLOOD GLUCOSE. REGISTERED NURSE NOTICED THAT THE RELIZORB ATTACHED TO THE ELECARE 30 KILOCALORIES/OUNCE WAS CRACKED OFF THE PATIENT G TUBE (GASTROSTOMY TUBE) EXTENSION. THE ORANGE CONNECTOR PIECE OF THE RELIZORB REMAINED DISLODGED IN THE ATTACHED G TUBE EXTENSION, WHILE THE FEEDS WERE POURING INTO PATIENT BED. PROVIDER WAS NOTIFIED, G TUBE EXTENSION WAS REPLACED. HOWEVER, OTHER REGISTERED NURSES HAVE VOICED THAT THIS IS AN ONGOING ISSUE WITH THIS PATIENT, IN PREVIOUS NIGHTS MULTIPLE RELIZORB CARTRIDGES HAVE CRACKED LEADING TO DECREASED BLOOD GLUCOSE. LOT NUMBER FOR RELIZORB IS 3423910000.