For oem manufacturing sites: in this mdr, (b)(4).Device evaluated by mfr a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 10-mar-2023.Bd received 3 samples and 1 video for investigation.The video was reviewed and the indicated failure mode for backflow was observed, however the tourniquet was removed too early in the blood collection process.According to the bd vacutainer evacuated blood collection system ifu (instructions for use), to prevent backflow the patient's arm should be placed in a downward position, the tube should be held with the stopper uppermost, and the tourniquet should be released only when blood starts to flow into the blood collection tube.These three steps were not followed in the submitted video.The customer samples were evaluated by visual examination and functional testing, each used to draw water into bd vacutainer tubes, and the indicated failure mode for backflow with the incident lot was not observed as all product specifications were met.Additionally, 50 retention samples from bd inventory, were evaluated by visual examination and no issues that could cause backflow were observed.An additional 8 retention samples were evaluated by functional testing, each used to draw bd vacutainer tubes with colored water, and no issues were found relating to backflow as all specifications were met.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode backflow.Bd determined that the root cause of the indicated failure mode was attributed to user error.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
|