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 there is a dark vertical line through the ultrasound image due to an internal failure within the gt probe.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.H3 other text : evaluation findings are in section h.11.
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