Objective: To investigate the potential for embolisation, due to the piercing of suspect rubber seals ('coring') of intravenous (IV)-solution bottles by the sharp (plastic, non-patient end) spike of commonly used infusion sets.
Methods: The suspect seals of 50 bottles were pierced with an infusion-set spike and the respective solutions were examined for visible particles, filtered and the filtrate examined both macroscopically and microscopically. As controls, 36 IV-solution bottles of other brands with pierced seals and 10 units of the suspect brand with unpierced seals were examined in the same way.
Results: Macroscopic and microscopic particles (maximum longest axis > 1 mm), including fibrils, were invariably present in the solutions from bottles with pierced suspect seals, but no such debris was detected in the control solutions.
Conclusions: The defectively packaged solutions (from B. Braun) have been used extensively in at least 21 different countries during the past decade and, unknown to clinicians, constituted a source of potential rubber emboli. The multinational manufacturer responsible has largely rectified the fault. Discovery of such defects requires prompt reporting to relevant government departments and the manufacturer, so that appropriate action may be taken nationally and internationally. Good manufacturing practice and drug regulatory surveillance should extend to the way in which the final packaged forms are used.