Model Number 383313 |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/08/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the bd saf-t-intima w/y adapter yel 24ga x.75i experienced leakage.The following information was provided by the initial reporter: "the patient has leakage after puncture.
|
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d.9.Device available for eval: yes.D.9.Returned to manufacturer on: 01-sep-2022.Investigation summary: our quality engineer inspected the 1 sample and 2 photos submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the samples.Bd determined that the cause of the failure cannot be associated to the manufacturing process since there are several non-manufacturing related causes that could have resulted in this failure.Production records were reviewed, and this batch was in compliance with our product specification requirements.A notification was sent to the proper manufacturing personnel to inform them of the defect.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.
|
|
Event Description
|
It was reported that the bd saf-t-intima w/y adapter yel 24ga x.75i experienced leakage.The following information was provided by the initial reporter: "the patient has leakage after puncture.
|
|
Search Alerts/Recalls
|