MalfunctionKCP
EAR ULCER SYRINGE
Received May 16, 2019 · Event occurred May 10, 2019
Report 8615217 · MDR key 8615217
Device
Generic name
Syringe, Ent
Manufacturer
Medline Industries, Inc.Model number
RI13CSICatalog number
DGN00280
Lot number
96918030001
Product problems
- Tear, Rip or Hole in Device Packaging
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE RESPIRATORY THERAPIST OPENED THE STERILE PACKAGE TO USE THE BULB SYRINGE AND NOTED THAT THE SEAM AROUND THE BULB PART WAS NOT FUSED TOGETHER.