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, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the device was returned to the service facility with no alleged deficiency reported.During evaluation, it was found the probe displays rain like image due to an internal probe failure.A history review of serial number (b)(6) showed one similar complaint from this serial number.The similar complaints have been reported by the same us facility.The previous complaint evaluations for this serial number ((b)(6)) are: inconclusive, no sample returned for evaluation.(reference: mdr number 3006260740-2020-02627).
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