Catalog Number 382523 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/18/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd insyte autog bc blu 22ga x 1.0in experienced needle retraction failure.The following information was provided by the initial reporter: "needle not retracting on 22ga x 1".
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Manufacturer Narrative
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Investigation results: the complaint that the needle would not retract could not be confirmed from the 20 representative 22g insyte autoguard units that were received from lot #3236004.A visual and functional test of the returned samples revealed nothing remarkable.Each needle fully retracted when the safety mechanism was activated.Although the representative samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
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Event Description
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No additional information.
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Search Alerts/Recalls
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