BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER SST II ADVANCE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
|
Back to Search Results |
|
Model Number 367957 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/05/2021 |
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.(b)(4).
|
|
Event Description
|
It was reported that after centrifugation with bd vacutainer® sst¿ ii advance gel smearing occurred.This occurred on 10 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: gel issues description of the problem: the gel after centrifugation stretches / flows / delaminates / disintegrates.Clods / balls formed, clog and stick to the outside, analyzer needle (cobas).
|
|
Event Description
|
It was reported that after centrifugation with bd vacutainer® sst¿ ii advance gel smearing occurred.This occurred on 10 separate occasions, however, the patient impact was not reported.The following information was provided by the initial reporter: gel issues description of the problem: the gel after centrifugation stretches / flows / delaminates / disintegrates clods / balls formed, clog and stick to the outside, analyzer needle (cobas).
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-03.H6: investigation summary bd received 4 samples and 7 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for gel globules with the incident lot was observed.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for gel globules with the incident lot was observed.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.
|
|
Search Alerts/Recalls
|
|
|