Catalog Number 381023 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle would not retract.The following information was provided by the initial reporter.The customer stated: "the hcp pressed the button to activate the safety mechanism; however, the needle was not retracted.".
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Manufacturer Narrative
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H6: investigation summary our quality engineer inspected the sample and photographs submitted for evaluation.Bd received one unit and three photos.Upon inspection of the received unit and the photos it was identified that the button had been pressed but retraction did not occur.The reported defect was confirmed.Further inspection revealed that adhesive was present on the outside of the needle well (hub), which created a larger diameter than the grip and prevented retraction from occurring.During manufacturing, adhesive may be incorrectly placed due to adhesive build up or part misalignment.Preventative maintenance and in process sampling are performed at regular intervals to mitigate the risk from this type of defect.A device history record review could not be performed as the lot number is unknown.H3 other text : see h10.
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Event Description
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It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter the needle would not retract.The following information was provided by the initial reporter.The customer stated: "the hcp pressed the button to activate the safety mechanism; however, the needle was not retracted.".
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Search Alerts/Recalls
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