NEOSEAL NEONATAL NASAL PRONG SEAL
Received Feb 20, 2025 · Event occurred Jan 24, 2018
Report MW5166558 · MDR key 21423581
Device
Generic name
Clip, Nose
Manufacturer
Neotech Products, LlcPatient
3 DA · Female
- Dyspnea
- Low Oxygen Saturation
- Foreign Body In Patient
- Pulmonary Hypertension
- Dyspnea
- Low Oxygen Saturation
- Foreign Body In Patient
- Pulmonary Hypertension
Narrative
Description of Event or Problem
TERM, FEMALE INFANT WAS HOSPITALIZED FOR PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN. SHE INGESTED FOAM, NEONATAL NASAL CANNULA SEAL AT THE NEGLIGENCE OF HOSPITAL NEONATAL INTENSIVE CARE UNIT STAFF. INFANT HAD PROLONGED HOSPITAL STAY AND HAD TO BE SEDATED MULTIPLE TIME FOR STRUGGLING TO BREATH. OXYGEN LEVELS CONTINUED TO DECLINE. SEDATION WAS NEEDED TO CALM INFANT BECAUSE OF PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN DIAGNOSIS AND RISK OF FURTHER PULMONARY ISSUES WHEN CRYING/BEING UPSET. TWO WEEKS AFTER ADMISSION, PATIENT WAS RELEASED AND SENT HOME. MOTHER DISCOVERED CANNULA SEAL IN A BOWEL MOVEMENT THREE DAYS AFTER BEING SENT HOME. RISKS AND HARM OF INFANT INGESTING THIS SEAL WERE INFINITE. THE HARM DONE AND RISK OF SUFFOCATION WERE INFINITE. INCIDENT OCCURRED AT (B)(6) HOSPITAL NEONATAL INTENSIVE CARE UNIT IN (B)(6) THE WEEK OF (B)(6) 2018. WHATEVER PRODUCTS WERE USED FOR CPAP DEVICES IN THE NEONATAL INTENSIVE CARE UNIT ARE A RISK FOR INGESTION AND DEATH BY SUFFOCATION OF INFANTS.