Two Instances of Manufacturing Defects in Venous Indwelling Needles

Abstract

  Intravenous indwelling needles are widely used in intravenous sedation and perioperative management for general anesthesia. We report two cases in which cracks were observed near the hub of indwelling needles. The first patient was a 47-year-old woman with dental phobia who was scheduled to receive dental treatment under intravenous sedation. Peripheral intravenous access was secured using the BD Insyte^TM Autoguard^TM BC Pro 24G, manufactured by Becton, Dickinson and Company. Immediately after initiating the infusion, fluid leakage was observed near the connection between the intravenous needle and the IV circuit. The intravenous needle was removed, and another intravenous needle was used to resecure the venous access. The second patient was a 39-year-old woman who was scheduled to undergo an intramaxillary foreign body removal after sagittal splitting of the mandibular ramus under intravenous sedation. An intravenous line was established using the above-mentioned product from the same company and an infusion was initiated ; immediately afterwards, however, the infusion began to leak from the indwelling needle. In both cases, the intravenous access was resecured, and intravenous sedation was performed without any subsequent problems. When the removed indwelling needles were examined, cracks were found near the hub of the indwelling needles in both cases. Safety inspections are necessary before using medical devices, but unexpected problems can occur. In such cases, both early problem recognition and appropriate responses are necessary.