Model Number 381834 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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¿ autoguard¿ catheter i.V.20g x 1.16¿ had the needle partially retract.The following information was provided by the initial reporter: "after venipuncture, when pressing the button to activate the safety device, it did not retract the needle in its entirety".
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Manufacturer Narrative
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H6: investigation summary: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 1215054, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the needle was partially retracted.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.H3 other text : see h10.
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Event Description
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It was reported that bd insyte¿ autoguard¿ cateter i.V.20g x 1.16¿ had the needle partially retract.The following information was provided by the initial reporter: "after venipuncture, when pressing the button to activate the safety device, it did not retract the needle in its entirety.".
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Search Alerts/Recalls
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