MCKESSON BRANDS
Received Dec 14, 2023 · Event occurred Nov 30, 2023
Report 1451040-2023-00063 · MDR key 18325742
Device
Generic name
Evacuator, Silicone Bulb 100ml
Manufacturer
Conod Medical Co., LimitedCatalog number
16-322160
Product problems
- Leak/Splash
- Suction Problem
- Leak/Splash
- Suction Problem
Patient
Unknown
- Fluid Discharge
- Fluid Discharge
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT THE BULB EVACUATOR WAS DEFECTIVE CAUSING THE DRAIN TO LEAK FOLLOWING SURGERY FOR BREAST AUGMENTATION. THEY HAD TO GO BACK AND DO ANOTHER PROCEDURE TO SEE WHY THERE WAS LEAKAGE. THEY CHECKED TO ENSURE THERE WAS NOTHING DONE INCORRECTLY ON THEIR END. THEY TOOK THE BULB OFF AND CHECKED BOTH AND REALIZED THE BULB WAS DEFECTIVE AND WAS CAUSING THE LEAK. THE BULB WAS REPLACED, AND THE ISSUE WAS RESOLVED. THIS EXTENDED THE OPERATING TIME BY TWO HOURS.
Additional Manufacturer Narrative
MANUFACTURER INFORMATION CORRECTED IN SECTIONS D3 AND F14. INITIAL REPORT WAS FILED DECEMBER 14, 2023.