inforMED
MalfunctionJLK

RIGHTSPOT PH ENFIT INDICATOR

Received Mar 24, 2021 · Event occurred Mar 2, 2021

Report 11562469 · MDR key 11562469

Device

Generic name

Sodium Hydroxide And Phenol Red (titrimetric), Gastric Acidity

Manufacturer

Rightbio Metrics

Catalog number

RSEN001

Lot number

EN0920201

Product problems

  • Gas/Air Leak

Patient

Not reported

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

NG TUBE INSERTED TO 19CM. RIGHTSPOT PH ENFIT INDICATOR ATTACHED TO CHECK PLACEMENT. WHEN ASPIRATING TO CHECK PLACEMENT, AIR CONTINUED TO COME BUT NO FLUID. WHEN PH INDICATOR DETACHED FROM THE END OF THE NG TUBE AND FEEDING SYRINGE ATTACHED, <1ML AIR WAS ABLE TO BE ASPIRATED. ANOTHER RIGHTSPOT PH INDICATOR WAS OBTAINED AND USED WITH THE SAME RESULTS. PH INDICATORS CHECKED FOR CRACKS, BUT NO CRACKS WERE OBVIOUSLY VISIBLE. NG PLACEMENT DOUBLE CHECKED WITH ANOTHER RN BY AUSCULTATION AND ASPIRATION. BUBBLES AUSCULTATED OVER THE STOMACH AND SMALL AMOUNTS OF BREASTMILK/FORMULA ABLE TO BE ASPIRATED FROM THE NG WITH A FEEDING SYRINGE. RIGHTSPOT PH INDICATOR & PACKAGING SAVED IN A BAG.