| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNOMETER 500 | URINOMETER, MECHANICAL | UNOMEDICAL LTD. | EXR | 25104742 | 190839 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-08-06 | 0 |
Patient 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient 1
IT WAS REPORTED THAT DURING ROUTINE OBSERVATION OF THE PATIENT, THE PATIENT AND BED WERE FOUND SOAKED AND THE URINARY CONNECTOR DEVICE ON THE URINE METER WAS DISCONNECTED FROM THE CATHETER. THE CATHETER WAS RECONNECTED AND THERE WERE NO FURTHER ISSUES REPORTED. THE USER ALSO REPORTED THAT IT WAS UNKNOWN HOW LONG THE CATHETER HAD BEEN DISCONNECTED BUT THERE WAS NO SKIN BREAKDOWN AS A RESULT OF THE URINE SPILLAGE.
Patient 1
ADDITIONAL INFORMATION WAS RECEIVED FROM THE CRITICAL CARE ACCOUNT EXECUTIVE TO CLARIFY COMPLAINT DETAILS: THIS USER FACILITY HAS REPORTED PROBLEMS IN THE PAST OF THE DISCONNECTION BETWEEN THE SILICONE CATHETERS AND CONNECTORS BEING A RECURRING ISSUE WHICH WAS DEALT WITH BY A COLLEAGUE. I DID NOT TAKE RESPONSIBILITY FOR THIS PRODUCT RANGE UNTIL (B)(6) 2015. FOR CLARIFICATION I AM REPORTING THIS ONE INSTANCE, THOUGH I AM AWARE OF A PREVIOUSLY SUBMITTED COMPLAINT FOR THE SAME ISSUE FROM THIS FACILITY. A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED ON AUGUST 24, 2015. NO SAMPLE WAS RETURNED TO ASSIST WITH THE INVESTIGATION. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A DETAILED BATCH REVIEW, NO DISCREPANCIES RELATED TO THE COMPLAINT ISSUE WERE FOUND. THE ISSUE IS RELATED TO THE FOLEY CATHETER, WHICH IS NOT A PART OF PRODUCT. NO INFORMATION ABOUT THE CATHETER WAS PROVIDED. NO CHANGES RELATED TO 3K-CONNECTOR WERE IMPLEMENTED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED, AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).