inforMED
OtherMOU

ALPHA IV REV.2, 30MM ACTIVE TRANSFER DEVICE

Received Oct 3, 2001 · Event occurred Jun 14, 2001

Report 1062385-2001-00010 · MDR key 355775

Device

Generic name

Transfer Device

Model number

A1732

Catalog number

WLC-0001-032/TDA-0030-032

Lot number

NA

Product problems

  • Other (for use when an appropriate device code cannot be identified)
  • Component Missing

Patient

*

  • Other (for use when an appropriate patient code cannot be identified)
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

COMPLAINANT REPORTED THAT THEY RAN OUT OF WATER IN THE SYRINGE AND WERE NOT PREPARED WITH A SECONDARY SYRINGE TO REPLACE IT. THIS CAUSED AN INCREASE IN TREATMENT TIME BY 23%. A SECONDARY SYRINGE IS PROVIDED WITH EACH PROCEDURE ACCESSORY PACK.