Catalog Number RF048F |
Device Problems
Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Material Deformation (2976)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The lot number was provided for the one malfunction; therefore, a lot history review has been performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced migration of device or device component and material deformation.This information was received from one source.This malfunction involved one patient with no patient consequences.There was no provided patient information.
|
|
Manufacturer Narrative
|
H10: the reported malfunction was reassessed for reportability and determined to be reportable as a serious injury, and were reported under emdr 2020394-2021-80202.H10: the lot number was provided for the one malfunction; therefore, a lot history review has been performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
|
|
Event Description
|
This report summarizes one malfunction.A review of the reported information indicated that model rf048f vena cava filter allegedly experienced migration of device or device component, material deformation and perforation.This information was received from one source.This malfunction involved one patient with no patient consequences.The 31 year old male patient was 135 lbs.
|
|
Search Alerts/Recalls
|