BECTON, DICKINSON & CO. (SPARKS) BD PHOENIX AST-S BROTH; SYSTEM, TEST, AUTOMATED ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
|
Back to Search Results |
|
Model Number 246007 |
Device Problem
Contamination of Device Ingredient or Reagent (2901)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/17/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
It was reported that while using bd phoenix¿ ast-s broth contamination was observed by the laboratory personnel.A gram stain was used to confirm the results as false positives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer is reporting contamination with lot 1020655.".
|
|
Event Description
|
It was reported that while using bd phoenix¿ ast-s broth contamination was observed by the laboratory personnel.Customer gram stained the growth, which turned out to be over decolorized large gram positive rod (bacillus morph).There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer is reporting contamination with lot 1020655.".
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-18.Investigation summary: investigational testing was performed using the returned sample tube.The returned sample was analyzed by qc and contamination was identified as bacillus simplex.The complaint investigation also included a review of quality notifications on the complaint batch for this defect.There was one quality notification on the complaint batch, however it was not related to this defect.A review of previous complaints were performed and there were no additional complaints on this batch.Complaint trending was performed and no trends were identified for this batch or defect.No further corrective action is required because no complaint trends exist.The following fields were updated with corrections: b.5.Event description: it was reported that while using bd phoenix¿ ast-s broth contamination was observed by the laboratory personnel.Customer gram stained the growth, which turned out to be over decolorized large gram positive rod (bacillus morph).There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: " customer is reporting contamination with lot 1020655.".
|
|
Search Alerts/Recalls
|
|
|