MEDISORB MULTI-ABSORBER ORIGINAL, DISPOSABLE
Received May 28, 2021 · Event occurred Apr 19, 2021
Report 3002807637-2021-00018 · MDR key 11904885
Device
Generic name
Absorbent, Carbon-dioxide
Manufacturer
Vyaire MedicalModel number
MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLECatalog number
8003138
Lot number
0970120
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. BUT THE DHR (DEVICE HISTORY RECORD) AND PHOTO ANALYSIS HAS BEEN REQUESTED. HOWEVER, AT THIS TIME, NO ROOT CAUSE COULD BE DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LEAK WAS DETECTED ON 8003138 MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE DURING SURGERY. THERE WAS NO HEALTH HAZARDS HAVE BEEN REPORTED TO PATIENTS AT THIS TIME.