Model Number 367955 |
Device Problem
Device Ingredient or Reagent Problem (2910)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/02/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes trace of red blood cells on tube and sometimes remains on the surface of the tube after it spins.The following information was provided by the initial reporter.The customer stated: "sst tube lot 2171047 exp 31/12/23 - trace of red blood cells on tube and sometimes remains agglomerated on the surface of the tube itself after centrifugation.".
|
|
Manufacturer Narrative
|
H.6.Investigation summary: bd had not received samples or photos for evaluation.A complaint history review was performed and revealed a confirmed complaint trend for certain sample quality issues.Based on the confirmed complaint trend a capa (corrective and preventive action) was initiated.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for red cell hang up based on the trend identified.A corrective and preventive action was created to address the issue.
|
|
Event Description
|
It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tubes trace of red blood cells on tube and sometimes remains on the surface of the tube after it spins.The following information was provided by the initial reporter.The customer stated: "sst tube lot 2171047 exp 31/12/23 - trace of red blood cells on tube and sometimes remains agglomerated on the surface of the tube itself after centrifugation.".
|
|
Search Alerts/Recalls
|