CHAIT ACCESS ADAPTER
Received Apr 13, 2017
Report 1820334-2017-00650 · MDR key 6490511
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
INTERNATIONAL CUSTOMER / PATIENT REPORTED THAT THE CLAMP WAS BROKEN RESULTING IN LEAKAGE OF WATER FROM THE DEVICE. THE DEVICE IMPLANT DATE WAS NOT PROVIDED. THE LEAKAGE WAS OBSERVED IN THE CONNECTING TUBE. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF TWO REPORTS BEING SUBMITTED AS THE REPORTER / PATIENT INDICATED TWO SEPARATE EVENTS. SEE MDR NUMBERS 1820334-2017-00650 AND 1820334-2017-00651 FOR EACH ASSOCIATED EVENT.