inforMED
MalfunctionFPK

LIFESHIELD

Received Feb 27, 2017 · Event occurred Feb 6, 2017

Report 6360201 · MDR key 6360201

Device

Generic name

Iv Tubing Extension

Manufacturer

Hospira, Inc.

Lot number

66132NS

Product problems

  • Device Contamination with Chemical or Other Material

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

IV THERAPY NURSE REPORTS THAT PATIENT WAS BEING ASSESSED FOR NEW PIV SITE IN THE RIGHT ARM. NO CURRENT PERIPHERAL IV'S OR MEDICATIONS INFUSING IN THE RIGHT UPPER EXTREMITY. ACCESSED VEIN IN RIGHT FOREARM WITHOUT DIFFICULTY WITH #22 GAUGE ANGIO. ATTACHED NEWLY OPENED SALINE LOCK, ASPIRATED BLOOD AND FLUSHED WITH 10 ML NS. SALINE LOCK WAS IN SEALED PACKAGE PRIOR TO CONNECTION WITH NO OBVIOUS ABNORMALITIES. POST FLUSH AND CLAMPING OF SALINE LOCK, THERE WAS A GRAY PARTICULATE MATTER THAT APPEARED INTERNALLY WITHIN THE SALINE LOCK TUBING. SITE WAS ASSESSED BY ANOTHER RN AND THE SALINE LOCK WAS PROMPTLY REMOVED AND REPLACED WITH NEW SALINE LOCK, ASPIRATED, AND FLUSHED WITH 10 ML NS WITHOUT INCIDENT.