NAMIC
Received Jan 12, 2026 · Event occurred Dec 15, 2025
Report 3015910259-2026-00004 · MDR key 24045428
Device
Generic name
Syringe,10ml,angio,w/ra,-,oem
Manufacturer
Medline Industries, Lp - NamicCatalog number
80085007
Product problems
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE SYRINGE "KEPT UNTWISTING" AND COULD NOT BE USED FOR THE PROCEDURE. THE CUSTOMER REPORTED THAT THERE WAS A "5 MIN" DELAY RELATED TO THE REPORTED ISSUE, BUT THERE WAS NO INDIVIDUAL INJURED AS A RESULT. THE CUSTOMER DID NOT REPORT ANY SERIOUS INJURY, MEDICAL INTERVENTION REQUIRED, OR FOLLOW-UP CARE NEEDED AS A RESULT OF THE REPORTED ISSUE. NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. 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.
Description of Event or Problem
IT WAS REPORTED THAT THE SYRINGE "KEPT UNTWISTING" AND COULD NOT BE USED FOR THE PROCEDURE. THE CUSTOMER REPORTED THAT THERE WAS A "5 MIN" DELAY RELATED TO THE REPORTED ISSUE, BUT THERE WAS NO INDIVIDUAL INJURED AS A RESULT.