MALLINCKRODT
Received May 10, 2018
Report 2936999-2018-00336 · MDR key 7503496
Device
Product problems
- Inflation Problem
- Inflation Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
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, WHEN THE UNIT WAS TAKEN OUT OF THE BOX AND INFLATED, THE MAIN BALLOON WAS NOTED TO LEAK AND HAD A SMALL HOLE IN IT.
Additional Manufacturer Narrative
EVALUATION SUMMARY: ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE FAILURE TEAR IN CUFF WAS CONFIRMED IN THE RECEIVED SAMPLE. DEVICE HISTORY RECORD WAS NOT REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. MANUFACTURING PROCESS WAS REVIEWED AND CURRENTLY, THERE IS NOT ANY POTENTIAL RISK AND THE BELOW CONDITION WAS FOUND. DESCRIBE THE GUIDELINES TO HAVE A RESTING TIME OF 4 HOURS WITH INFLATED CUFFS AND THEN THE PARTS ARE INSPECTED FOR PROPER INFLATED CUFFS. ALL MANUFACTURING CONTROLS WERE FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. 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.
Description of Event or Problem
ACCORDING TO THE REPORTER, WHEN THE UNIT WAS TAKEN OUT OF THE BOX AND INFLATED, THE MAIN BALLOON WAS NOTED TO LEAK AND HAD A SMALL HOLE IN IT. THERE WAS NO PATIENT INVOLVEMENT.