|
Model Number BREVDRV-02 |
Device Problem
Failure to Obtain Sample (2533)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/18/2023 |
Event Type
Injury
|
Event Description
|
It was reported that on october 18th, a brevera procedure was performed and the staff had a driver error during the procedure, which was unable to be clear.The needle inserted into patient breast, unable to collect samples.The patient is rescheduled for a new procedure.No additional information available.
|
|
Manufacturer Narrative
|
Di: (b)(4).D4: lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.H3: the device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
|
|
Search Alerts/Recalls
|
|
|