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 the information, the following was concluded: the device was returned to the service facility for evaluation.During evaluation, the reported issue of cord is pulling away at the strain relief was confirmed.The probe's scanner head has been pulled away from the strain relief.The root cause is probe failure due to use of device.H3 other text : evaluation findings are in section h.11.
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