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: found during evaluation of original file: the dc connector on the power supply that was provided with this unit is broken, the strain relief is cracked and the wires are broken internally exposing the wires.The root cause is due to use of the device.H3 other text : evaluation findings are in section h11.
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