SAFEDRAW¿
Received Jul 15, 2026 · Event occurred Jun 8, 2026
Report 8020616-2026-00038 · MDR key 25824878
Device
Generic name
System, Measurement, Blood-pressure, Non-invasive
Manufacturer
Merit Medical Singapore Pte Ltd.Catalog number
689710/B
Lot number
C2914083
Product problems
- Human-Device Interface Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE FOUND. DURING PRODUCT HISTORY REVIEW, NO EXCEPTION DOCUMENTS WERE FOUND.
Description of Event or Problem
IT WAS REPORTED THAT WHEN THE TUBING WAS RINSED, BLOOD WAS JETTED OUT OF THE DEVICE'S COLLECTION MEMBRANE THAT WAS PLACED ON THE PATIENT. BLOOD SPLASHED INTO THE EYES OF A NURSING STAFF. NO PATIENT INCIDENT.