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Canadian Journal of Anesthesia 47:601 (2000)
© Canadian Anesthesiologists' Society, 2000

Correspondence

Paint chips and glass ampoules

Mark L. Glube, MD and Judith Littleford, MD BSc FRCPC

Toronto, Ontario

To the Editor:

Many pharmaceutical manufacturers use paint stripes to help identify their ampoules. We would like to warn their users of the potential risk for drug contamination when a paint stripe is applied over the "scored" neck of a glass ampoule.

Our pharmacy purchases fentanyl from Faulding (Canada) Inc. Their glass ampoules (2ml size) have a yellow stripe of paint around the "scored" neck of the ampoule.(FigureGo) The ampoule is "snapped" open in the usual fashion by placing the top between the thumb and the proximal phalanx of the index finger.



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  		FIGURE Fentanyl ampoule. Note the paint chip floating on the surface of the liquid

 
On two separate occasions, a fleck of yellow paint was noticed to be floating on the surface of the liquid inside the ampoule. It was evident on careful inspection that a portion of the yellow paint from the outside of the ampoule was missing. Presumably, the paint chip became detached from the glass and fell into the ampoule while it was being opened. This was noticed prior to intrathecal injection of the medication in both instances.

There have been several case reports of drug contamination by glass particles when opening glass ampoules.1-3 In such instances, the use of a filter needle may guard against the intrathecal injection of particulate matter. However, the outside surface of the ampoule is certainly not sterile. If the paint chip had gone unnoticed, a solution that was potentially contaminated with bacteria could have been administered.

Acknowledgments

The authors wish to thank John Hendrix for providing the photograph and Michael Heffer for pharmaceutical advice.

References

1 Katz H, Borden H, Hischer D. Glass particle contamination of color-break ampules. Anesthesiology 1973; 39: 354.[Medline]

2 Carbone-Traber KB, Shanks CA. Glass particle contamination in single-dose ampules. Anesth Analg 1986; 65: 1361–3.[Free Full Text]

3 Turko S, Davies N. Glass particles in intravenous injections. N Engl J Med 1972; 287: 1204.

 
Scott Armour

Regulatory Affairs Associate Faulding Canada Inc.

Thank you for your letter. On November 12, 1999, we received information from Mr. Heffer at The Mount Sinai Hospital concerning a report of a paint fleck in an ampoule of fentanyl citrate, as a result of opening the ampoule. A reply was sent to Mr. Heffer the same day, informing him that an alternate ampoule format was currently under evaluation. Another follow-up response was sent on Jan. 26, 2000.

Faulding have now completed trials investigating an alternate ampoule proposed for use with fentanyl citrate. This information is now under review to determine how this design may be introduced to the Canadian market. We take all comments from our customers seriously as we recognise their value in helping to improve the excellence of our products and services. As such, we appreciate the opportunity to comment on the letter and to share the actions of our company.





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