H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a defective safety mechanism was unconfirmed as the problem could not be reproduced.One 20 ga x 0.75 in miniloc infusion set was returned for evaluation.The safety mechanism was not engaged over the needle bevel.The extension tubing was clamped.No obvious evidence of use was noted on the device.The needle housing and wings appeared to be intact with no evidence of damage.The safety mechanism was advanced and was able to be successfully activated over the needle bevel.No resistance was felt during advancement.The safety mechanism was manipulated in order to test for potential deactivation.The mechanism stayed intact, and no issues were noted.Since the safety mechanism of the returned device was found to function as intended, the complaint could not be confirmed at this time.
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