inforMED
MalfunctionOGJ

ARROW CONTINUOUS NERVE BLOCK SETG

Received Mar 27, 2015 · Event occurred Feb 12, 2015

Report 1036844-2015-00092 · MDR key 4651088

Device

Generic name

Anesthesia Conduction Kit

Manufacturer

Arrow Intl., Inc.

Catalog number

AB-19608-S

Lot number

23F13L0074

Product problems

  • Cut In Material
  • Difficult to Advance

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE CUSTOMER ALLEGES THAT ON INSERTION THE DOCTOR EXPERIENCED DIFFICULTY TO ADVANCE THE STIMUCATH THROUGH THE INSULATED PLEXUS BLOCK NEEDLE. THE STIMUCATH GOT STUCK IN THE NEEDLE. WHEN THE DOCTOR PULLED THE STIMUCATH BACK, THE TIP OF THE NEEDLE CUT THE STIMUCATH CATHETER. THE STIMUCATH CATHETER AND INSULATED PLEXUS BLOCK NEEDLE WERE REMOVED COMPLETELY. ANOTHER ATTEMPT WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY OR COMPLICATION REPORTED.

Additional Manufacturer Narrative

QN# (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.