MalfunctionLHI
VIAL MATE SYSTEM
Received Aug 9, 2018 · Event occurred Aug 1, 2018
Report MW5079034 · MDR key 7772501
Device
Generic name
Set I. V. Fluid Transfer
Manufacturer
Sterigenics Us LlcProduct problems
- Detachment of Device or Device Component
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
(B)(6) 2018, PART OF GREY STOPPER IN SOLUTION AFTER BEING ACTIVATED. VIAL MATE SYSTEM: USING AZITHROMYCIN 500MG VIAL, AUROMEDICS LOT # CAM180007, EXP: 04/2020. VIAL MATE SYSTEM USED FOR AZITHROMYCIN 500MG VIAL. WHEN VIAL MATE SYSTEM WAS ACTIVATED, A SMALL PIECE OF THE RUBBER STOPPER FROM THE AZITHROMYCIN VIAL WAS IN THE RECONSTITUTED SOLUTION. THE IVPB WAS NOT ADMINISTERED.