TELEFLEX MEDICAL SDN. BHD. HUMID-VENT FILTER COMPACT STRAIGHT; FILTER, BACTERIAL, BREATHING-C
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Model Number IPN043768 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).
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Event Description
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It was reported that prior to use while assembling the tubing, the filter does not stay attached to the tubing and disconnects from the whisper swivel valve easily, even if the tubing is not moved.Additional information received states that the filters are compatible with the swivel valve.No patient involvement.
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Manufacturer Narrative
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(b)(4).A representative sample was returned to investigation site for evaluation.The device was reviewed as part of the investigation.The device was visually inspected where no issues were found.Functional testing was conducted on the representative sample through a gauge test and the connector was found to be within specification.In current manufacturing practice, all devices are subjected to a 100% visual inspection.Any devices which show defects are removed from the production line.A device history record (dhr) review was conducted and no issues that could have contributed to the reported event were identified.The manufacturing related root cause of the reported event could not be as the returned representative sample was found to be in specification and without issue.Teleflex will continue to monitor and trend for complaints of this nature.The associated mdr numbers identified were 8040412-2023-00197, 8040412-2023-00198 and 8040412-2023-00221.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that prior to use while assembling the tubing, the filter does not stay attached to the tubing and disconnects from the whisper swivel valve easily, even if the tubing is not moved.Additional information received states that the filters are compatible with the swivel valve.No patient involvement.
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Search Alerts/Recalls
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