Hospira Safety Precautions when Opening Ampuls

Posted Thursday, January 16, 2014

January 16, 2014

IMPORTANT SAFETY INFORMATION
Product: Ampuls
Subject: Safety Precautions when Opening Ampuls
ACTION REQUIRED
Dear Health Care Provider,
Hospira is issuing this Important Safety Information letter to remind Healthcare Providers to
follow facility protocol and exercise caution when opening an ampul. Hospira has received
reports of ampuls not properly breaking along the score lines. If an ampul is open without proper
precaution and if the score line varies in depth, the break may not be clean and leave a sharp
edge or shatter. A sharp edge may potentially pose a physical risk to the Health Care Provider
as well as a delay in therapy. Always refer to specific facility policies and procedures for opening
an ampul.
The breaking off/shattering of the head and neck on an ampul which is difficult to open, may
result in spillage of drug. Drug spillage may lead to exposure to equipment, flooring, and
personnel. Physical injury may result in a localized wound, which may result in infection and/or
scarring, as well as exposure to the drug substance by the Health Care Provider opening the
ampul. A delay in therapy may occur while another ampul is procured.
The root cause of hard to break glass potentially relates to adjustments made on the scoring
system by the glass manufacturer. Hospira continues to work with the supplier to institute
process controls that minimize the potential for these events.
For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 (24
hours a day / 7 days a week) or e-mail Medcom@hospira.com. To report product complaints or
adverse events call 1-800-441-4100 (M-F, 8am to 5pm CT) or e-mail
productcomplaintspp@hospira.com.

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