Catalog Number 8065751613 |
Device Problems
Leak/Splash (1354); Sticking (1597)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/30/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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The customer reported that they had trouble with a leaky valve during a procedure.The procedure was completed successfully with no harm to the patient, no plugs were needed.One of the "flaps" was stuck in open position.This is a second of two complaints from this facility.
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Manufacturer Narrative
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A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there is one additional complaint associated with the lot for the reported issue.One opened trocar hub was received in a bag for the report of leaking.The returned sample was visually inspected and was found non-conforming with a cut in the septum.The exact root cause for this complaint is unknown, however, a potential contributing factor related to the manufacturing process of the valves has been identified.An investigation has been completed and actions are presently being implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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