The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
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The reported event is unconfirmed.Photo samples were submitted, however, could not be evaluated for the reported failure.The extension cable returned without the original packaging.Gross visual evaluation: no damage to the cord was noted.Connections of the cords to the plug and socket were secure.Using a multimeter, the cord was tested for and found to have continuity.The cord was connected to an in-house temperature sensing catheter submerged in a water bath set at 37 degrees celsius, the cord was then attached to a kilo device and the temperature displayed 37.0 degrees celsius and then stabilized at 37.1 degrees celsius, similar to the thermometer reading.The samples meet the specification "plug and jack must be firmly secured to wire." no root cause could be found because the reported event was unconfirmed.The lot number is unknown; therefore, the device history record could not be reviewed.The reported event is unconfirmed a labeling review is not required.Section a through f - the information provided by bd represents all 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.
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