Model Number IPN922810 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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Reported issue: the doctor found tube blocked when using it on the patient.The device was replaced with a new one.There was no patient impact.
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Event Description
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Reported issue: the doctor found tube blocked when using it on the patient.The device was replaced with a new one.There was no patient impact.Additional information received 31-mar-2023: "the device wasn't pre-tested, the device was inserted in the patient, then the clinician cannot insert the suction tube through the tube.Then immediately changed new one,no impact on patient.".
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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