Our quality engineer inspected the 1 photo and 1 used sample submitted for evaluation.The reported issue of catheter broke/separated after placement was confirmed upon inspection of the samples.Analysis of the photo and sample showed that the catheter was broken off from the rest of the device.However, the cannula tip of the device was not returned for evaluation.Without all the sample components, we are unable to fully investigate the sample, so a manufacturing related root cause could not be determined.We do have automated vision reject systems in our manufacturing process that are able to detect and reject any products with this type of damage.There is a possibility that the failure could have occurred during product application or removal from packaging.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
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