Catalog Number 251176 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/13/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that there was an occurrence of 10 with bbl - mueller hinton agar with 5% sheep blood media that was found to be contaminated before unpacking.No patient impact was reported.The following information was provided by the initial reporter: this is a report about contamination of the media.The customer found that the media was contaminated before unpacking.
|
|
Manufacturer Narrative
|
In this mdr, bd ds headquarters in sparks, md has been listed as fukushima is an oem manufacturing site.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
H.6 investigation summary: 251176.#2200283.We couldn't confirm this issue as a report because no photo and returned sample.Complaint history was reviewed, and no other complaint has been taken on this lot.At this time.Device history record review (dhr) did not indicate any discrepancies.All release testing was satisfactory and no deviations were observed.It includes bioburden testing.A visual inspection was performed on 20 retention samples of this lot.As a result, no contamination was observed.The root cause for this could not be determined we will continue to monitor this lot.
|
|
Event Description
|
It was reported that there was an occurrence of 10 with bbl - mueller hinton agar with 5% sheep blood media that was found to be contaminated before unpacking.No patient impact was reported.The following information was provided by the initial reporter: this is a report about contamination of the media.The customer found that the media was contaminated before unpacking.
|
|
Search Alerts/Recalls
|