The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 device was not returned.
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The device was not returned for evaluation.A potential failure mode could be ¿torn rubberize¿.A potential root cause for this failure could be "insufficient latex strength or low/ non uniform rubberize thickness".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "1.The foley catheter with temperature sensor should not be connected to the temperature monitoring equipment during the mri procedure.2.If the foley catheter with temperature sensor has a removable catheter connector cable, it should be disconnected prior to the mri procedure.3.Remove all electrically conductive material from the bore of the mr system that is not required for the procedure (i.E., unused surface coils, cables, etc.).4.Keep electrically conductive material that must remain in the bore of the mr system from directly contacting the patient by placing thermal and/or electrical insulation (including air) between the conductive material and the patient.5.Position the foley catheter with a temperature sensor in a straight configuration down the center of the patient table to prevent cross points and conductive coils or loops.6.The wire and connector of the foley catheter with temperature sensor should not be in contact with the patient during the mri procedure.Position the device, accordingly.7.Mr imaging should be performed using an mr system with static magnetic strength of 1.5-tesla or 3-tesla, only.8.At 1.5-tesla, the mr system whole body averaged sar should not exceed 3.5- w/kg for 15-min.Of scanning.9.At 3-tesla, the mr system reported whole body averaged sar should not exceed 3-w/kg for 15-min of scanning." 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.H3 other text : the device was not returned.
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