InjuryGBX
ANGIO DYNAMICS DRAIN CATHETER, 10FR APD
Received Oct 5, 2020 · Event occurred Sep 11, 2020
Report MW5097082 · MDR key 10634409
Device
Generic name
Catheter, Irrigation
Manufacturer
Angiodynamics, Inc.Model number
14000804Lot number
5553379
Product problems
- Break
Patient
84 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
CATHETER BROKE INSIDE OF PATIENT SPONTANEOUSLY. ANGIO DYNAMICS GENERAL DRAINAGE CATH OCKING PIGTAIL 10 FR. 30 CM. ON (B)(6) 2020 PIGTAIL REMOVED. PRODUCT 10FR APD DRAIN LOT 5553379, PRODUCT #14000804, ANGIODYNAMICS REP WAS NOTIFIED. FDA SAFETY REPORT ID# (B)(4).