Description of Event or Problem · 0
THERE WAS A DEFECT WITH A PRODUCT UTILIZED IN THE (B)(6) NEONATAL ICU. THE PRODUCT IS CALLED NEOSEAL AND IS USED ON NASAL RESPIRATORY DEVICES TO ENHANCE THE SEAL. AN INFANT IN THAT NICU WAS REPORTED BY THE PARENT TO HAVE COUGHED UP A PIECE OF THIS, SO WE ARE REACHING OUT TO SEE WHERE WITHIN THE HEALTH SYSTEM THIS PRODUCT IS BEING UTILIZED. THE (B)(6) NICU HAS SWEPT THE PRODUCT AT THIS TIME, AND I AM GOING TO DRAFT A PATIENT SAFETY ALERT AS WELL. PARENT SENT A PICTURE TO THE CARE PROVIDERS. DR. [REDACTED NAME] "THIS BABY USED SIZE SMALL AS FULL-TERM BABY. I AM NOT SURE IF WE CAN SAY THAT BATCH IS DEFECTIVE BUT HIND SIDE BABIES PULL CPAP TO MOUTH MANY TIMES SO THEORETICALLY ANY PRODUCT THAT IS SMALL ENOUGH TO BE SWALLOWED COULD BE AN ISSUE. A LEARNING POINT FOR ALL OF US." SHE IS IN FAVOR OF REMOVING THIS PRODUCT. SAYS THIS CAN HAPPEN WITH THE SMALL PIECES WHEN BABIES ARE SUCKING ON THE CPAP PIECES. BABY WAS SEEN IN PEDI GI ON [REDACTED DATE], WILL DO AN UPPER GI SERIES IN TWO WEEKS TO ASSESS IF THERE IS A RESULT IN STRICTURE FROM THIS. FAMILY DISCARDED THE PIECE. CLINICAL LEADERSHIP WAS IN FAVOR OF IMMEDIATELY REMOVING THIS PRODUCT ALL TOGETHER FOR SAFETY REASONS. THE PATIENT WAS SEEN BY PEDIATRIC GASTROENTEROLOGY (GI) AND THEY WERE GOING TO PERFORM AN UPPER GI SERIES IN A COUPLE OF WEEKS TO DETERMINE IF HARM/STRICTURE HAVE OCCURRED AS A RESULT OF THIS FOREIGN OBJECT. OF NOTE, THIS COULD HAVE BEEN THE CONTRIBUTING FACTOR TO THE BABY¿S GERD (GASTROESOPHAGEAL REFLUX DISEASE). OUTCOME UNKNOWN.