inforMED
MalfunctionKCP

MEDLINE REINER EAR SYRINGE

Received Dec 12, 2018 · Event occurred Oct 24, 2018

Report MW5082072 · MDR key 8160302

Device

Generic name

Syringe, Ent

Model number

MDS 4409710

Catalog number

NA

Lot number

00081619

Product problems

  • Break
  • Detachment of Device or Device Component

Patient

69 YR

  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Foreign Body In Patient
  • Hemorrhage/Blood Loss/Bleeding
  • Pain
  • Foreign Body In Patient

Narrative

Description of Event or Problem

WHILE FLUSHING THE RIGHT EAR USING THE DEVICE, THE TOP OF THE SYRINGE POPPED OFF PROPELLING THE TIP OF THE SYRINGE DEEPER INTO THE PT'S EAR CANAL CAUSING PAIN AND BLEEDING. DIAGNOSIS OR REASON FOR USE: EAR WAX IMPACTION.