BROSELOW WHITE INTUBATION MODULE

Description of Event or Problem

IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING THE RESUSCITATION OF A PATIENT, THE BROSELOW, INTUBATION MOD, WHITE, 2PK WAS CRACKED BY AN ER STAFF> UPON INSPECTION THE DEVICE HAD A MISSING MALE END TO ATTACH THE WALL SUCTION TO THE NG. THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT BUT HAD A DELAY IN DECOMPRESSION BECAUSE OF LOOKING FOR A REPLACEMENT.

Additional Manufacturer Narrative

AT THIS TIME, THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION BECAUSE THERE WAS NO DAMAGED ON THE PRODUCT BUT ONLY HAS A MISSING MALE END. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

DEVICE EVALUATION:G3,G6,H2, AND H10. RESULT OF INVESTIGATION:THE SUSPECT DEVICE WAS NOT AVAILABLE FOR EVALUATION. HOWEVER, THE REPORTED LOT NUMBER 0004129376 IDENTIFIED THAT THE NG TUBE THE CUSTOMER REPORTED IN THE COMPLAINT IS THE SUBASSEMBLY PART NUMBER R7710NGA (USED FOR THE MANUFACTURE OF THE FG 770WIN). DUE TO A SUPPLIER CHANGE UNDER (B)(4), ALL THE PRODUCTS MANUFACTURED AFTER OCTOBER 2019 WOULD NOT COME WITH THE MALE END ADAPTER, FOR THIS REASON THE NG TUBE DID NOT COME WITH THE MALE END ADAPTER SINCE THE REPORTED LOT NUMBER WAS MANUFACTURED ON 12MAR2020. THEREFORE, THE DEFECT REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.