Model Number 392544 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd insyte¿ autoguard¿ bc pro seems to be defective.The following information was provided by the initial reporter: that seem to be defective.Wont retract.
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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.Device expiration date: unknown.Device manufacture date: unknown.
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Manufacturer Narrative
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H6: investigation summary there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record could not be performed as the reported lot, 2194268, could not be found as a viable batch in the product records for material number 392544.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ bc pro seems to be defective.The following information was provided by the initial reporter: that seem to be defective.Wont retract.
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Search Alerts/Recalls
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