Model Number 382637 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: our quality engineer inspected the photograph submitted for evaluation.The photo displayed the labels of two packages from material #382637, lot #0190042.Visual observation of the photo revealed there was no view of a device for investigation.Unfortunately, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Additional inspections or investigation into the reported defect could not be performed without the physical sample.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that while using a bd insyte¿ autoguard¿ bc catheter the needle would not retract.There was no report of patient or user impact. the following information was provided by the initial reporter: it was reported by the medical professional, needle did not retract into the housing.
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Manufacturer Narrative
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Investigation summary: our quality engineer inspected the photograph submitted for evaluation.The photo displayed the labels of two packages from material #382637, lot #0190042.Visual observation of the photo revealed there was no view of a device for investigation.Unfortunately, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.Additional inspections or investigation into the reported defect could not be performed without the physical sample.A device history record review showed no non-conformance's associated with this issue during the production of this batch.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that while using a bd insyte¿ autoguard¿ bc catheter the needle would not retract.There was no report of patient or user impact. the following information was provided by the initial reporter: it was reported by the medical professional, needle did not retract into the housing.
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Search Alerts/Recalls
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