Investigation summary: the batch record for the lot was reviewed, no related abnormalities were found during the manufacturing process.Additionally a sample was provided for the purpose of aiding our quality engineer's investigation, the tip shield of the device was noted by bd engineers as not being separated from the catheter adapter at the time of review.During closer observation it was noted that the v-clip of the device had not activated during use of the product.The v-clip was successfully activated by engineers through the slight application of force.Since the manufacture of this lot, bd has optimized the design of the v-clip t eliminate the reoccurrence of event like this.Investigation conclusion: the indicated failure mode was observed in the returned sample.No abnormality found in the incoming material, the whole assembly process and packing process.Root cause description: according to current investigation, in-activation of complaint failure mode cased by the tilted v-clip.
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The batch record for lot#7292179 was reviewed, no related abnormalities were found during the manufacturing process.A sample was provided for the purpose of aiding our quality engineer's investigation, the tip shield of the device was noted by bd engineers as not being separated from the catheter adapter at the time of review.During closer observation it was noted that the v-clip of the device had not activated during use of the product.The v-clip was successfully activated by engineers through the slight application of force.Since the manufacture of this lot# bd has optimized the design of the v-clip to eliminate the reoccurrence of events like this.Bd will continue to track and trend for this issue.
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