Results - bd received one 20ga consisting of a catheter-adapter assembly along with a handwritten note, the needle-barrel assembly was not returned for evaluation.Upon examination, the catheter tubing was slightly curved, there was a v-shape cut in the catheter tubing indicative of needle spear through, and no foreign matter was observed.A device history record review showed no rejected inspections or quality issues during the production of the reported lot numbers that could have contributed to the defects of foreign matter and needle retraction failure.Conclusion - the needle retraction failure could not be confirmed or investigated since the needle assembly was not returned for evaluation.A root cause for this incident could not be determined.
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