Arterial catheter was inserted in radial on (b)(6) 2023, repositioned on (b)(6) 2023 as catheter stopped working after 3 days.Catheter was occluded, it was impossible to sample and rinsing the catheter.There was no consequence for the patient.Doctors had to re-insert the device.
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns the user, "indwelling catheter should be routinely inspected for desired patency, security of dressing, and possible migration." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Arterial catheter was inserted in radial on (b)(6) 2023, repositioned on (b)(6) 2023 as catheter stopped working after 3 days.Catheter was occluded, it was impossible to sample and rinsing the catheter.There was no consequence for the patient.Doctors had to re-insert the device.
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