Catalog Number CS-27702-E |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/09/2023 |
Event Type
malfunction
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Event Description
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It was reported the luer/hub fitting connection was found leaking during use on the patient.The alleged issue occurred with 5 devices on the same patient during the same event.No patient harm was reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.
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Manufacturer Narrative
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(b)(4).Associated mdr#s: 3006425876-2023-00184; 3006425876-2023-00185; 3006425876-2023-00186; 3006425876-2023-00182.
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Event Description
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It was reported the luer/hub fitting connection was found leaking during use on the patient.The alleged issue occurred with 5 devices on the same patient during the same event.No patient harm was reported.The patient's condition is reported as fine.Additional information was requested but was not available at the time of this report.
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Manufacturer Narrative
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(b)(4).Associated mdr#s: 3006425876-2023-00183; 3006425876-2023-00184; 3006425876-2023-00185; 3006425876-2023-00186; 3006425876-2023-00182.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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