Catalog Number 297882 |
Device Problem
Contamination (1120)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/06/2022 |
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 that prior to use, one sleeve of bd bbl¿ pseudosel¿ agar plates was contaminated.The following information was provided by the initial reporter: customer reports that bd bbl¿ pseudosel¿ agar (cetrimide agar) plate 10pk "297882" lot # 2126082" is contaminated.
|
|
Manufacturer Narrative
|
This supplemental mdr is to cancel mfr report #1119779-2022-00945.Clarifying information was provided by the customer: plates were not contaminated.They failed a qc test for growth.The following information was provided by the initial reporter: "pseudosel (cetrimide) agar, lot 2126082 was received on 25may2022 and growth promotion testing and contamination check testing were initiated on 25may2022.Growth promotion testing failed due to no growth for atcc 9027 on the pseudosel plates lot 2126082.Testing was repeated, and confirmed that lot 2126082 had no growth for atcc 9027.All inoculation verification plates met acceptance criteria, rendering the tests valid.The contamination check for lot 2126082 met the acceptance criteria.".
|
|
Event Description
|
It was reported that prior to use, one sleeve of bd bbl¿ pseudosel¿ agar plates was contaminated.The following information was provided by the initial reporter: customer reports that bd bbl¿ pseudosel¿ agar (cetrimide agar) plate 10pk "297882" lot # 2126082" is contaminated.
|
|
Search Alerts/Recalls
|