NAMIC
Received Mar 31, 2026 · Event occurred Mar 9, 2026
Report 3015910259-2026-00106 · MDR key 24746791
Device
Generic name
Syringe,10ml,angio,w/ra,-,oem
Manufacturer
Medline Industires, Lp- NamicCatalog number
80085007
Lot number
0000156801
Product problems
- Loose or Intermittent Connection
- Connection Problem
Patient
NA · Unknown
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY, THEY STARTED LOSING CONNECTION OF SYRINGE AND MANIFOLD AFTER INJECTING 50 ML OF CONTRAST DURING CORONARY ANGIOGRAM, THEN SYRINGE STARTED SPINNING OUT ITSELF. UNABLE TO KEEP IT ATTACHED. NO ADDITIONAL INFORMATION AT THIS TIME. 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
ACCORDING TO THE FACILITY, THEY STARTED LOSING CONNECTION OF SYRINGE AND MANIFOLD AFTER INJECTING 50 ML OF CONTRAST DURING CORONARY ANGIOGRAM, THEN SYRINGE STARTED SPINNING OUT ITSELF. UNABLE TO KEEP IT ATTACHED.
Remedial action
- Recall