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Catalog Number 5-16037 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (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.Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "after intubation, y connector was found leaking, physician changed a new one".No patient harm, desaturation, or injury.The patient status is reported as "fine".
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Manufacturer Narrative
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(b)(4).The customer returned one unit 5-16037 et tube, sher-i-bronch, ls, 37 fr for investigation.Both swivel connectors and the y connector were returned out of their original packaging.The et tube and two suction catheters that come in the et tube kit 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.The swivel connector is a component purchased from a supplier.A device history record review was performed and no relevant findings were identified.The reported complaint is 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 capa was previously opened to further investigate this issue.Corrective actions were implemented under the capa on 15apr2022 to prevent this issue from recurring.The returned sample was manufactured prior to the corrective actions.
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Event Description
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It was reported that "after intubation, y connector was found leaking, physician changed a new one".No patient harm, desaturation, or injury.The patient status is reported as "fine".
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Search Alerts/Recalls
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