A healthcare worker in Little Elm has submitted a report to the Food and Drug Administration detailing a malfunction with a medical device intended to prevent needlestick injuries. The incident involves a VanishPoint II syringe manufactured by Retractile Technologies, Inc.
The report describes an event that occurred while the nurse was administering an ordered subcutaneous medication. Hospital protocol required the use of a standard safety needle for this procedure. The specific device involved was a tuberculin needle paired with a VanishPoint II syringe, identified by reference number 10131 and lot code G388A.
According to the filing, the nurse completed the injection as planned. However, the safety feature of the needle did not activate automatically or manually as designed. Instead of retracting into the barrel to cover the sharp tip, the needle remained extended outward.
The failure of the retraction mechanism left the sharp end exposed immediately after use. The report states that this malfunction nearly resulted in a needlestick injury to the healthcare worker. The nurse noted that the device continued to stay straight out rather than securing itself.
The MAUDE database, which tracks medical device adverse events, received this account of the equipment failure. The filing highlights a specific instance where the safety design did not function as intended during clinical use.
