The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
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The customer reported that during testing, it was noticed that the luer lock is shorter and with forceful and uncommon bending, they were able to remove the closed system drug transfer device (cstd).Additional information received from the customer stated that the issue was with the luer connection of monoject syringe.The cstd was not completely locking to the monoject syringes.There was no patient harm reported.
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