Catalog Number 251359 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/09/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.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 bd bbl¿ sabouraud dextrose agar slants had mold in most of all 20 unused plates.No patient impact reported.The following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, mold was found in most of all 20 unused plates.The customer would like to know if there is consideration regarding storage of the media.
|
|
Event Description
|
It was reported that bd bbl¿ sabouraud dextrose agar slants had mold in most of all 20 unused plates.No patient impact reported.The following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, mold was found in most of all 20 unused plates.The customer would like to know if there is consideration regarding storage of the media.
|
|
Manufacturer Narrative
|
H.6 investigation summary: we confirm this issue as a report from returned sample.The issue was contamination.No issue in device history record review.No issue in retention samples.No trend.We will continue to monitor this issue.
|
|
Search Alerts/Recalls
|