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 batch history, labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the protective packaging needle cover was missing was inconclusive due to the sample condition.The product returned for evaluation was a 22 ga x 0.75 in safestep infusion set.The device was returned with opened packaging.The safety mechanism had not been advanced.The plastic needle cover was not present within the packaging or on the needle shaft.A bend in the needle was present; however, it is unknown if the bend occurred during return of the sample.Based on evaluation of the returned sample, possible contributing factors include the cover not being assembled onto the device or the cover falling off during manufacturing, packaging, shipping or use.Because the kit had been opened, it cannot be concluded that the protective needle cover was not packaged in the kit.H3 other text : evaluation findings are in section h11.
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