Model Number 101/860/080CZ |
Device Problems
Disconnection (1171); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that during the pre-use check, the pilot balloon got detached from the inflation line.No patient injury.No additional information is available for this complaint.
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Manufacturer Narrative
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Device lot number is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
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Manufacturer Narrative
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Other text: manufacturing device history record review was not performed because the results of the complaint investigation is not batch related issue.A product sample was received for evaluation.Visual inspection found the inflation line was detached from pilot balloon.The cause of the reported problem was traced to the manufacturing process.This issue was escalated to an internal capa and occurrence is being monitored via trend analysis.If the occurrence of this issue increases significantly, additional corrective actions will be taken.Additional event information received.
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Event Description
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Additional information was received 2022-11-02 from manufacturer receiving facility: this event occurred during patient use, not during pre-use checks, as the returned product had residual patient fluids in the suction line.Additional information was requested to verify; however, no further information was received from the customer.
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Search Alerts/Recalls
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