MalfunctionNXZ
24HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION
Received May 8, 2018 · Event occurred Mar 20, 2018
Report 7494368 · MDR key 7494368
Device
Generic name
Oral Care Products
Manufacturer
Medline Industries IncCatalog number
MDS606804HP
Lot number
18-039-1
Product problems
- Break
- Detachment Of Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
WHEN NURSES PERFORM ORAL CARE FOR PATIENTS, THE SPONGES OF THE GREEN SUCTION SWABS FELL OFF INTO PATIENTS' MOUTHS. THIS EVENT HAPPENED ON THE MULTIPLE DAYS. MANUFACTURER RESPONSE FOR ORAL CARE PRODUCTS, 24 HR, WITH HYDROGEN PEROXIDE, ORAL SUCTION (PER SITE REPORTER): MEDLINE'S PRODUCT QUALITY TEAM DID INSPECTION ON THEIR SUCTION SWABS IN THE FACTORY AND ADDED EXTRA GLUE TO THE SWAB IN THE MANUFACTURING PROCESS. THEY REPLACED OUR STOCK WITH NEW LOTS.