UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Received Feb 26, 2016 · Event occurred Feb 2, 2016
Report 3007966929-2016-00007 · MDR key 5463536
Device
Product problems
- Obstruction of Flow
- Obstruction of Flow
Patient
71 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
HEIGHT: 160 FEET. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO LOT NUMBER OR PRODUCT EVALUATION SAMPLE IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED AND WILL BE MONITORED THROUGH OUR POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER, NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON FEBRUARY 26, 2016 (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE SPACE OF THE SAMPLING PORT IS BLOCKED WITH URINE SEDIMENT AND IT IS DIFFICULT TO TAKE THE SAMPLE.