MalfunctionNBG
ENDOINK
Received Jul 13, 2022 · Event occurred Apr 9, 2022
Report 14999540 · MDR key 14999540
Device
Generic name
Endoscopic Marker
Manufacturer
Micro-tech (nan Jing) Co., Ltd.Catalog number
ENK10
Lot number
M210719252
Product problems
- Leak/Splash
Patient
9855 DA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE LUER TIP OF THE ENDOINKTM ENDOSCOPIC MARKER LEAKED WHEN ATTACHED TO SYRINGE. A NEW SETUP WAS OBTAINED AND CASE CONTINUED WITHOUT INCIDENT. THE ORIGINAL DEVICE AND PACKAGING WERE DISCARDED AFTER NUMBERS ATTACHED, EDUCATION PROVIDED TO SAVE ITEMS EVEN IF MESSY.