MEDLINE
Received Jun 2, 2026 · Event occurred May 6, 2026
Report 1417592-2026-01988 · MDR key 25363203
Device
Generic name
Pressureplus Infusion Bag, 1000ml
Manufacturer
Medline Industries, LpCatalog number
DYNJPI1000C
Product problems
- Decrease in Pressure
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PRESSURE BAG DOES NOT MAINTAIN SET PRESSURE WHEN INFLATED LOSES ALL PRESSURE WITHIN 5 MINUTES, TESTED 5 TIMES. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
THE PRESSURE BAG DOES NOT MAINTAIN SET PRESSURE WHEN INFLATED LOSES ALL PRESSURE WITHIN 5 MINUTES, TESTED 5 TIMES.