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Catalog Number 5-16037 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(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 "the doctor found connector broken when doing clinical setting before using on patient.Then changed new one, no impact on patient.Involved 3 pcs and 1 patient." no patient involvement.See associated mdrs #3003898360-2023-01503, 3003898360-2 023-01510.
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Manufacturer Narrative
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(b)(4).The reported complaint of "broken/cracked - double swivel connector" 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 device history record review was performed, and no relevant findings were identified.An investigation was previously opened to further investigate this issue.Corrective actions were implemented under the investigation on 15apr2022 to prevent this issue from recurring.The returned sample was manufactured prior to the corrective actions.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that "the doctor found connector broken when doing clinical setting before using on patient.Then changed new one, no impact on patient.Involved 3 pcs and 1 patient." no patient involvement.See associated mdrs #3003898360-2023-01503, 3003898360-2 023-01510.
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Search Alerts/Recalls
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