Model Number IPN918647 |
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 03/27/2023 |
Event Type
malfunction
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Event Description
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It was reported after insertion, while the lines were checked, the physician observed there was no backflow on the distal line.A new catheter was inserted and the same issue occurred with the second catheter.It was decided to leave the second catheter inserted in the patient.No patient harm or consequence reported.
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Manufacturer Narrative
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Qn# (b)(4).Associated mdr#: 3006425876-2023-00363.
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Event Description
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It was reported after insertion, while the lines were checked, the physician observed there was no backflow on the distal line.A new catheter was inserted and the same issue occurred with the second catheter.It was decided to leave the second catheter inserted in the patient.No patient harm or consequence reported.
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Manufacturer Narrative
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(b)(4).Associated mdr#s: 3006425876-2023-00363 and 3006425876-2023-00362.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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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Search Alerts/Recalls
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