MalfunctionFKQ
CENTRISOL ACID CONCENTRATE
Received Sep 25, 2024 · Event occurred Aug 2, 2024
Report 2150060-2024-00048 · MDR key 20304390
Device
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
STERIS IS NOT THE MANUFACTURER OF THE CENTRISOL ACID CONCENTRATE SUBJECT OF THE REPORTED EVENT. STERIS HAS NOTIFIED THE MANUFACTURER, ROCKWELL MEDICAL, OF THE REPORTED EVENT TO INTERNALLY INVESTIGATE AND EVALUATE FOR REPORTABILITY. STERIS IS SUBMITTING THIS REPORT SOLELY IN RESPONSE TO THE RECEIVED MEDWATCH. NO ADDITIONAL ISSUES NOTED.
Description of Event or Problem
THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5157961 THAT THEIR SB-352 AND SB-353 JUGS OF CENTRISOL ACID CONCENTRATE HAD THE SAME COLOR AND STYLE LABELS. NO REPORT OF INJURY.