3611 LITE GLOVE
Received Aug 22, 2016
Report 9612030-2016-00379 · MDR key 5892859
Product problems
- Crack
- Out-Of-Box Failure
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
SUBMIT DATE: 08/22/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH A LITE GLOVE. THE CUSTOMER REPORTS A FAILURE OUT OF BOX. THE CUSTOMER FURTHER REPORTS THAT AT THE SEAM THERE IS A CRACK IN THE MATERIAL. NOT USE AT A PATIENT AND THE ISSUE WAS NOTICED BEFORE USE.
Additional Manufacturer Narrative
SUBMIT DATE: 11/09/2016. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE PERFORMED OR DATE OF MANUFACTURE IDENTIFIED AS THE LOT NUMBER WAS NOT PROVIDED. ALL DHR¿S ARE REVIEWED FOR QUALITY INSPECTIONS AND PARAMETER COMPLIANCE PRIOR TO RELEASING THE PRODUCT FOR DISTRIBUTION. A DECONTAMINATED SAMPLE WITHOUT ORIGINAL PACKAGE OR LOT NUMBER WAS RECEIVED AND THE REPORTED ISSUE WAS CONFIRMED; THE SAMPLE PRESENTS TEAR ALONG THE HANDLE. A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED EVENT. WHEN ROOT CAUSE(S) IS DETERMINED THE APPROPRIATE ACTIONS WILL BE TAKEN TO ADDRESS THE REPORTED CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED THIS COMPLAINT WILL BE REOPENED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.