Medical device brand name: bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 18ga 1.16in (1.3 x 30 mm).Investigation summary: our quality engineer inspected the photograph submitted for evaluation.Bd received one photo in black and white color.Visual inspection of the photo found that needle can be seen piercing the catheter tubing.The defect of needle through catheter was confirmed.Additionally there was black coloring on the distal end of the catheter and inside the needle tip, indicating that media was present on the device.Since the unit had been used and media was observed inside the unit, it is unlikely that the defect occurred during manufacturing as the device would have been received with the needle piercing through the catheter tubing, making a venipuncture attempt unlikely.A needle spear through may occur in the user setting during tip adhesion break, during venipuncture if the needle is advanced at a wrong angle, or if the needle is moved up and down the catheter tubing.A device history record review showed no non-conformances associated with this issue during the production of this batch.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.
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