Model Number 381823 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2021 |
Event Type
malfunction
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Event Description
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It was reported that during use with a bd insyte¿ autoguard¿ bc shielded iv catheter the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: this is a report about needle retraction failure of insyte autoguard.According to the customer's report, after venipuncture, the hcp pressed the button but the needle was not retracted.
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Manufacturer Narrative
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Medical device expiration date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Manufacturer Narrative
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H.6.Investigation: our quality engineer inspected the photographs and sample submitted for evaluation.Bd received five photographs and one unit.The photos display an iv device without the protective needle cover or catheter adapter assembly.The activation button is fully depressed and the needle is in the out position (not retracted).There are small traces of media in the flashback chamber.The unit received is found similar to the photographs submitted.Through the visual observation of the unit, the activation button is not depressed and the needle is in the fully out position.There is evidence of cured adhesive between the hub and the grip.There is no movement of the hub, which concludes that the misplaced adhesive, although it did not restrict the button from depressing, it did hinder the retraction of the needle which is confirmed with the observation of adhesive in this area.The bond between the grip and hub is broken by manipulation and the needle fully retracted, therefore confirming the misplaced adhesive to be the cause of the needle retraction failure.This was physical/mechanical evidence to confirm and support a manufacturing process related issue for the reported defect relating to the misplacement of adhesive.Dhr can't be performed due to unknown lot#.H3 other text : see h.10.
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Event Description
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It was reported that during use with a bd insyte¿ autoguard¿ bc shielded iv catheter the needle would not retract.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this is a report about needle retraction failure of insyte autoguard.According to the customer's report, after venipuncture, the hcp pressed the button but the needle was not retracted.
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Search Alerts/Recalls
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