MALLINCKRODT
Received Nov 12, 2019 · Event occurred Oct 17, 2019
Report 2936999-2019-00934 · MDR key 9310083
Device
Generic name
Airway, Esophageal (obturator)
Model number
5-18537Catalog number
5-18537
Lot number
19E0882JZX
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: D10, G4, H3, H6 H3 EVALUATION SUMMARY: WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE CARRIED OUT THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. MANUFACTURING CONTROLS ARE IN PLACE TO DETECT CUFF INFLATION/DEFLATION DEFECTS TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
EVALUATION SUMMARY: A SECOND SAMPLE OF DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. IT WAS OBSERVED THAT THE CUFF WAS NOT PROPERLY ASSEMBLED. AN INFLATION DEFLATION TEST WAS PERFORMED ON BOTH CUFFS OF THE TUBE AND IT WAS OBSERVED THE WHITE CUFF HELD THE AIR ALTHOUGH THE LATEX CUFF DEFLATED IMMEDIATELY. A VISUAL INSPECTION WAS PERFORMED ON THE LATEX CUFF AND IT WAS OBSERVED THE CUFF HAD A TEAR. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD TWO SMALL BRONCHIAL INTUBATION WHITE SLEEVES THAT ARE LEAKING AND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.