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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 03/17/2021 |
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, after the procedure was completed, the patient was resting in bed calm and inactive when the catheter came out of place.The patient reported that he did not pull on/out the catheter.The night shift nurse who found the dislodged catheter in the bed assessed the patient and the catheter and noted that the balloon of the catheter was completely deflated.There was no reported trauma or injury to the patient.The nurse called the urologist and a new catheter was reinserted.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 after being shortly after being secured requiring a new catheter to be placed.
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Search Alerts/Recalls
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