Description of Event or Problem · 1
THERE HAVE BEEN 5 REPORTED INSTANCES OF GREY NEOBAR FAILURE AT THIS HOSPITAL IN (B)(6) 2011. ALL OF THESE ISSUES WERE WITH NEOBARS FROM LOT#21800. ON 4 SEPARATE OCCASIONS, THE DUODERM PAD ADHESION FAILED AND THE BAR BECAME DISENGAGED FROM THE ADHESIVE TAB. IN OTHER WORDS, THE ADHESIVE TAB ADHERED TO THE PATIENT'S FACE, BUT THE GREY PLASTIC ARM CAME LOOSE FROM THE ADHESIVE CONNECTION, CAUSING PROBLEMS WITH THE INTUBATION. FOUR OF THE INCIDENTS OCCURRED TO THE SAME PATIENT.THERE WAS NO PERMANENT HARM TO ANY OF THE PATIENTS, BUT ONE PATIENT EXPERIENCED THE FOLLOWING DUE TO THE DETACHMENT OF THE NEOBAR "BAR": PT WAS COUGHING AND GAGGING ON SECRETIONS AND ETT AND NEOBAR BECAME LOOSE. THE RT IN ROOM WITH NURSE RETAPED NEOBAR, BUT PATIENT WAS GASPING AND COUGHING DUE TO LOW VOLUMES ON VENT, SO REMOVED ETT AND PAGED ANESTHESIA TO REINTUBATE. NICU ATTENDING CAME OVER TO ASSIST, AND INTUBATED PT WITH 4.0 ETT. PT WAS BAGGED DURING ENTIRE EVENT, NO LOC, BRADY AND DESAT INITIALLY, AND RECOVERED. THE 2ND PATIENT SELF EXTUBATED IN ONE INCIDENT, BUT WAS DISCOVERED AND WAS NOT HARMED.ALL NEOBARS OF THAT LOT NUMBER WERE PULLED FROM STOCK AND REPLACEMENTS HAVE ALREADY ARRIVED FROM THE NEOTECH PLANT. ACCORDING TO ANECDOTAL INFORMATION ON A LIST SERVE, AT LEAST 2 OTHER FACILITIES HAVE REPORTED THE SAME ISSUE. NO OTHER PROBLEMS HAVE BEEN REPORTED WITH THE NEW LOT OF GRAY NEOBARS, HOWEVER, ONLY ONE HAS BEEN PUT TO USE SO FAR.IT IS RECOMMENDED THAT THIS LOT NUMBER BE EVALUATED FOR A NATIONWIDE RECALL.======================MANUFACTURER RESPONSE FOR NEOBAR ETT(PER SITE REPORTER).======================THEY REPLACED THE STOCK OF LOT NUMBER'S AFFECTED WITH A NEW LOT NUMBER.