D.2.Medical device type: one additional code applies: jka.D2a: common device name: blood specimen collection device; intravascular administration set.E.1: initial reporter facility name: (b)(6).H.6.Investigation summary: "material #: 367324.Lot/batch #: 3032591.Bd received 1 sample and 1 photo for investigation.The sample and photo were reviewed and the customer¿s indicated failure mode for leakage was observed as the extension tubing is damaged.The extension tubing was caught in the packaging seal and a longitudinal breach was created in the tubing when the unit packaging was cut.The breach would have allowed fluid to leak from the extension tubing.Additionally, 50 retention samples from bd inventory were evaluated by visual examination, and another 12 by functional draw testing, and the issue of damaged tubing / leakage was not observed.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 has been confirmed for the indicated failure mode damaged tubing.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.".
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