UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER

Additional Manufacturer Narrative

A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED. A COMPLAINT SAMPLE WAS NOT RECEIVED TO ASSIST WITH THE INVESTIGATION. AFTER A DETAILED BATCH REVIEW, NO DISCREPANCIES RELATED TO COMPLAINT ISSUE WERE FOUND. A PREVIOUS INVESTIGATION IS APPLICABLE TO THIS COMPLAINT. THIS PREVIOUS INVESTIGATION IS CLOSED. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER ACTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

Description of Event or Problem

THE NURSE REPORTS SCARCE URINE DRAINAGE FROM THE PATIENT EVEN AFTER DOSES OF DIURETICS ADMINISTERED PER MEDICATION SCHEDULE. IT IS FURTHER REPORTED 'IN THE FOLLOWING HOURS 300 CUBIC CENTIMETERS' OF URINE WAS OBTAINED AND PATIENT WAS DIAGNOSED WITH URINARY RETENTION. THE NURSE ADDS ON (B)(6), 2015 THE FOLLOWING URINE OUTPUT FROM THE PATIENT WAS OBTAINED: AT EIGHTEEN HOURS 70CC, AT TWENTY HOURS 30CC AT WHICH TIME 10 MG OF FUROSEMIDE WAS ADMINISTERED 'IN ACCORDANCE TO THE SCHEDULE', AT TWENTY-TWO HOURS 35CC, AT TWENTY-FOUR HOURS 20CC. THE NURSE ADDS AT 02 AM ON (B)(6) 2015 THE PATIENT HAD 90 CC URINE OUTPUT AND RECEIVED 10MG OF FUROSEMIDE 'AS SCHEDULED'. THE URINE OUTPUT AT 04 AM ON (B)(6) 2015 WAS 300CC, AT 06 AM 200CC AND ON THE 'DAY SHIFT OF (B)(6) 2015 THERE ARE NO VARIABILITIES REPORTED IN RELATION TO THE DIURESIS DATA'. THE NURSE ADDS THE UNOMETER SAFETI PLUS WAS IN PLACE FOR THIRTEEN DAYS.

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.