KENDALL
Received Aug 25, 2017 · Event occurred Jul 25, 2017
Report 9612030-2017-05148 · MDR key 6822741
Device
Product problems
- Detachment Of Device Component
- Detachment Of Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(6) 2017 AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
THE CUSTOMER STATES THAT THE SPONGE TIP PIECE HAD DETACHED INSIDE THE PATIENT AND HAD TO BE RETRIEVED BY STAFF.
Additional Manufacturer Narrative
ONE UNUSED SAMPLE WITH LOT NUMBER 6285109364X WAS RECEIVED FOR EVALUATION. A SAMPLE ANALYSIS WAS PERFORMED; AS PART OF THE ANALYSIS THE SAMPLE WAS VISUALLY INSPECTED ACCORDING TO THE PRODUCT SPECIFICATION. THE SAMPLE DOES NOT PRESENT THE REPORTED CONDITION THEREFORE THE CONDITION COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCT THAT COULD HAVE LED TO THE CONDITION DESCRIBED BY THE CUSTOMER. THE DHR REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. BASED ON THE INFORMATION AVAILABLE IN THIS COMPLAINT REPORT THE CONDITION IS NOT CONFIRMED; THE SAMPLE WAS MANUFACTURED ACCORDING TO CURRENT PRODUCT SPECIFICATIONS, AND TESTED UNDER THE CURRENT ACCEPTANCE CRITERIA. A PRODUCTION NOTIFICATION WAS ISSUED TO ALL PERSONNEL TO ENSURE THAT THEY ARE AWARE ON THE CONDITION REPORTED BY THE CUSTOMER. THE CURRENT PROCESS IS RUNNING ACCORDING TO PRODUCT SPECIFICATIONS MEETING QUALITY ACCEPTANCE CRITERIA. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.