inforMED
MalfunctionGIO

AQUA-CAP

Received Jul 22, 2021 · Event occurred Jun 23, 2021

Report 12210605 · MDR key 12210605

Device

Generic name

Tube, Collection, Capillary Blood

Catalog number

7-000-0650-LHC

Lot number

0211

Product problems

  • Use of Device Problem
  • Obstruction of Flow
  • Output Problem

Patient

28 DA

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

A BLOOD GLUCOSE WAS DRAWN VIA HEEL STICK FOLLOWING PROTOCOL TO USE DRUMMOND SCIENTIFIC COMPANY 65UL AQUA-CAP CAPILLARY (MICROPIPETTES) GLUCOSE TUBES. THE BLOOD WAS DRAWN INTO THE 65UL AQUA-CAP CAPILLARY TUBE. WHEN THE BLACK PLUNGER WAS PLACED IN THE TUBE IMMEDIATELY AFTER DRAWING, THE BLOOD WAS CLOTTED INSIDE THE TUBE AND WOULD NOT BE DRAWN UP BY THE STATSTRIP GLUCOSE CONNECTIVITY METER ON THE NOVA MONITOR. THE PROCESS WAS REPEATED WITH A SECOND CAPILLARY GLUCOSE TUBE, AND AGAIN, IT CLOTTED. THE STATSTRIP GLUCOSE CONNECTIVITY METER WAS THEN USED DIRECTLY ON THE DROP OF BLOOD FROM THE INFANT'S HEEL. THE CONCERN IS THAT THE EQUIPMENT IS NOT WORKING CORRECTLY CAUSING BLOOD CLOTS. LOT # ON THE TUBES IS 0211.