Catalog Number 381867 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter safety mechanism failed to activate and retract the needle during use.The following information was provided by the initial reporter: "safety mechanism not working: pressing the button the mechanism does not activate.".
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Manufacturer Narrative
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Bd received 11 insyte autoguard 14 gauge units from lot 8268611 for evaluation.One unit was received outside of its packaging and 10 units were received still inside the sealed packaging.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical/mechanical damage.The opened unit was fully retracted inside the safety barrel.The unit was reset and retraction was successful with no resistance felt.Next, the sealed units were inspected and no physical/mechanical damage was found.Functional retraction tests were performed on each unit and retraction was successful with no resistance.Based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were observed a definitive root cause could not be determined.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter safety mechanism failed to activate and retract the needle during use.The following information was provided by the initial reporter: "safety mechanism not working: pressing the button the mechanism does not activate'.
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Search Alerts/Recalls
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