The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.A history review of serial number (b)(4), showed no other similar product complaint(s) from this serial number.
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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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 for evaluation.During evaluation, the reported issue of wires showing at junction of probe and cord is confirmed.The cord is separated from the strain relief on the probe end exposing the wires.The wires are showing at the junction of the probe and cords.The root cause of the reported issue is due to use of the device.H3 other text : evaluation findings are in section h11.
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