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Model Number DYND11502 |
Device Problems
Material Rupture (1546); Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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It was reported that a patient was undergoing an unspecified surgical procedure and prior to the procedure being performed the surgeon placed a catheter while the patient was in the operating room.Reportedly, later that night, after the procedure was complete, the nurse found the patient standing at the bedside with the catheter already dislodged.There was no reported trauma or injury to the patient.The nurse called the urologist who attempted to place a new foley at the bedside but was not able to do so.The patient was sent back to the operating room to insert a new foley which was noted as complicated.The actual sample was disposed of and is not available to be returned for evaluation.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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Event Description
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It was reported that the balloon of the catheter became fully deflated and the catheter fell out of the patient shortly after being secured requiring a new catheter to be placed.
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Search Alerts/Recalls
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