Practitioners' Reporting News

Plastic Ampul Mix-up

Issued May 31, 2005

USP has received numerous reports via the Medication Errors Reporting (MER) Program on the problems with the current labeling of plastic ampuls. Below is an example of the problem faced at many facilities. Practitioners should be alerted to this potential mix-up.

Error description: In the emergency department, a suture kit contained Shur-Clens® for wound cleansing. Nursing staff also obtained Xylocaine®-MPF 1% for pain control. The physician accidentally injected Shur-Clens into the wound instead of Xylocaine-MPF. The patient complained of burning and no pain relief during the procedure. Both products are packaged in plastic ampuls. Xylocaine-MPF has black lettering and states "NOT FOR INHALATION." The Shur-Clens states "Not for injection," but it has embossed lettering that is difficult to read. The packaging is similar for both products, and the physician was new to the facility and not familiar with the contents in the hospital's suture kit. Also, the physician had never used Shur-Clens before but did recognize that infiltration of the medication was more difficult than it should have been.


Photo of Xyclocaine-MPF and Shur-Clens*

Reporting pharmacist's recommendation: The facility will now stock the emergency department with Xylocaine-MPF vials instead of the plastic ampuls.

USP's Center for the Advancement of Patient Safety greatly appreciates the reports submitted on these products and would like to provide the following links as additional information on the topic:

FDA Draft Guidance for Industry—Inhalation Drug Products Packaged in Semipermeable Container Closure Systems

Drug Safety and Risk Management Advisory Committee meeting on low-density polyethylene plastic vials

Similar medication errors can be submitted to the MER Program via a secure online form or by calling 1-800-23-ERROR (1-800-233-7767) to request a reporting form.

*Photos provided courtesy of the reporter or the Institute for Safe Medication Practices.


Readers are advised that official USP cautions and warnings for drugs appear in the USP–NF or USP DI. Unless otherwise indicated, any advice or opinions expressed herein reflect solely the judgment of USP staff. Such statements are intended for further consideration and evaluation and may or may not be applicable to a particular practice. The USP Medication Errors Reporting Program is presented in cooperation with the Institute for Safe Medication Practices.