NS-3600-B LITE GLOVE 1000/CASE
Received Dec 5, 2016
Report 9612030-2016-00781 · MDR key 6146139
Product problems
- Torn Material
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON 11/19/2016 THAT AN ISSUE OCCURRED WITH AN ENTERAL FEEDING PUMP. THE CUSTOMER REPORTS THE LITE GLOVE SPLITS AND FALLS OFF WHEN PUTTING IT ON LIGHT. THE LIGHT HANDLE COVERS RIPPING DURING PLACEMENT ON THE LIGHT HANDLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED.
Additional Manufacturer Narrative
SUBMIT DATE: 12/08/2016. SECTION WAS UPDATED TO CORRECT THE ITEM THAT WAS MENTIONED IN THE DESCRIPTION OF THE EVENT AND TO ADD ADDITIONAL INFORMATION BASED ON INFORMATION RECEIVED FROM THE CUSTOMER ON 12/07/2016. SECTION WAS CHANGED FROM: IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH AN ENTERAL FEEDING PUMP. THE CUSTOMER REPORTS THE LITE GLOVE SPLITS AND FALLS OFF WHEN PUTTING IT ON LIGHT. THE LIGHT HANDLE COVERS RIPPING DURING PLACEMENT ON THE LIGHT HANDLES. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH NO RESPONSE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED. TO: IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH LITE GLOVES. THE CUSTOMER REPORTS TWO LITE GLOVES SPLIT AND FALL OFF WHEN PUTTING IT ON THE LIGHT DURING SET UP ON AN UNKNOWN HANDLE. GLOVE LITE GLOVES WERE PLACED. NO PATIENT INVOLVEMENT.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT AN ISSUE OCCURRED WITH LITE GLOVES. THE CUSTOMER REPORTS TWO LITE GLOVES SPLIT AND FALL OFF WHEN PUTTING IT ON THE LIGHT DURING SET UP ON AN UNKNOWN HANDLE. GLOVE LITE GLOVES WERE PLACED. NO PATIENT INVOLVEMENT.