NAMIC
Received Jan 12, 2026 · Event occurred Dec 15, 2025
Report 3015910259-2026-00006 · MDR key 24039990
Device
Generic name
Syringe,10ml,angio,w/ra,-,oem
Manufacturer
Medline - NamicCatalog number
80085007
Lot number
0000159984
Product problems
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPDATED B4, D3, D9, E1, G6, H3.
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY, THE HAND INJECTION IS FAULTY, NOT SEALING/SCREWING IN, AND SPONTANEOUSLY UNSCREW ITSELF. THE FACILITY STATED THERE IS AN AIR EMBOLISM RISK BUT THERE WAS NO INJURY. 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. NO DEMOGRAPHIC INFORMATION WAS PROVIDED, BUT "0"KG WAS ENTERED SINCE THE PORTAL WILL NOT ACCEPT THIS FIELD BLANK.
Description of Event or Problem
ACCORDING TO THE FACILITY, THE HAND INJECTION IS FAULTY, NOT SEALING/SCREWING IN, AND SPONTANEOUSLY UNSCREW ITSELF. THE FACILITY STATED THERE IS AN AIR EMBOLISM RISK BUT THERE WAS NO INJURY.