TELEFLEX MEDICAL HUDSON ET TUBE, SHER-I-BRONCH, LS, 35 FR; TUBE, TRACHEAL/BRONCHIAL, DIFF
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Model Number IPN048995 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed and no relevant findings were identified.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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Reported issue: after intubation, when the clinician was trying to connect with y connector, it broke.
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Manufacturer Narrative
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(b)(4).The customer returned one unit 5-16035 et tube, sher-i-bronch, ls, 35 fr for investigation.The y connector and both swivel connectors were returned.The et tube and suction catheters were not returned.The returned connectors were visually examined with and without magnification.Visual examination of the returned samples revealed that the bronchial swivel connector was broken on the 15mm side.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed based on the sample received.The bronchial swivel connector was broken on the 15mm side.The swivel connector is a component purchased from a supplier.A non-conformance was previously opened to further investigate this issue.Corrective actions were implemented under the non-conformance on 08jan2022 to prevent this issue from recurring.This sample was manufactured prior to the corrective actions.
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Event Description
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Reported issue: after intubation, when the clinician was trying to connect with y connector, it broke.A new device was used without issue.The condition of the patient is reported as "fine".
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Search Alerts/Recalls
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