Monoject 401SGRecalls & reported problems
Cardinal Health, Inc. · Enteral Syringe with Tip Cap · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521140967), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Choking1
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT THEY USED THE PRODUCT IN THE NEWBORN NURSERY TO RESERVE THE MOTHER'S BREAST MILK IN REFRIGERATOR UNTIL IT WAS READY TO FEED PER HOSPITAL PROTOCOL. THE FATHER OF THE PATIENT RETRIEVED THE SYRINGE TO FEED THE BABY UNAWARE OF THE CAP ON THE TIP OF THE SYRINGE. WHEN THE FATHER SQUEEZED THE MILK INTO THE BABY'S MOUTH IT CAUSED THE CAP TO BECOME LODGED IN THE BABY'S THROAT RESULTING IN CHOKING. EMERGENCY CHOKING PROCEDURES WERE UNDERTAKEN, WHICH INCLUDED BACK BLOWS AND CHEST COMPRESSIONS FOR ABOUT A MINUTE. THE PATIENT IS NOW DOING WELL.
Patient problems: Choking; Foreign Body In Patient
MAUDE report 8799213 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.