EXCELSIOR MEDICAL ZR® FLUSH
Received Apr 2, 2026 · Event occurred Mar 5, 2026
Report 2027791-2026-00009 · MDR key 24765554
Device
Generic name
Syringe, 3ml Saline In 10ml
Manufacturer
Excelsior Medical, LlcCatalog number
EMZE010035
Lot number
3145382
Product problems
- Contamination
- Precipitate in Device or Device Ingredient
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ACCORDING TO THE CUSTOMER CONTACT, "THE PRODUCT WAS GOING TO BE USED TO FLUSH AN IV CATHETER WHEN THE LVT NOTICED AN UNUSUAL FILM ON THE INSIDE OF THE SYRINGE." THE CUSTOMER CONTACT REPORTED, "WE SAW WHAT APPEARS TO BE A CONTAMINATE IN THE SYRINGE" AND DESCRIBED AN "ODD PRECIPITATE ON INSIDE OF SYRINGE AND RUBBER STOPPER."
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER CONTACT, "THE PRODUCT WAS GOING TO BE USED TO FLUSH AN IV CATHETER WHEN THE LVT NOTICED AN UNUSUAL FILM ON THE INSIDE OF THE SYRINGE." THE CUSTOMER CONTACT REPORTED, "WE SAW WHAT APPEARS TO BE A CONTAMINATE IN THE SYRINGE" AND DESCRIBED AN "ODD PRECIPITATE ON INSIDE OF SYRINGE AND RUBBER STOPPER." THE CUSTOMER CONTACT STATED, THE PRODUCT WAS "PULLED FROM USE" AND "NEVER USED ON A PATIENT." NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE CUSTOMER REPORTED INCIDENT. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED FOR THE REPORTED PROBLEM/ISSUE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.