Catalog Number NS381834 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
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Event Description
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It was reported that bd insyte autoguard needle did not retract.The following information was provided by the initial reporter, translated from chinese to english: safety mechanism is not work.The steel needle cannot be retracted.
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Manufacturer Narrative
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Investigation results: the complaint that the needle safety did not work was confirmed from the photograph that was provided for investigation.The photo showed an insyte autoguard needle and shield with evidence of use.The needle remained fully extended from the grip.Without the physical sample, the root cause of the damage could not be determined.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.Investigation conclusion(s): the complaint of ¿needle retraction failure¿ was confirmed.Probable root cause(s): undetermined.
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Event Description
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No additional information.
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Search Alerts/Recalls
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