MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD¿ ¿COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD; BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

Catalog Number 257306

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It has been reported that the bd¿ columbia cna agar with 5% sheep blood has been found contaminated.The following has been provided by the initial reporter: plates contaminated with staphylococcus equorom.

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 has been reported that the bd¿ columbia cna agar with 5% sheep blood has been found contaminated.The following has been provided by the initial reporter: plates contaminated with staphylococcus equorom.

Manufacturer Narrative

H6: investigation summary it was reported that some plates would have been contaminated with staph.Equorum.The complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was performed and this issue will be investigated within a capa (corrective and preventive action) 4344556.The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Pictures were provided showing the reported contamination.The retention samples were reviewed and the plates were found to be without deviation.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.We only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.As several complaints were reported for this product lot number regarding contamination, a mrb (mrb 22-006) and capa (# 4344556) were created for further evaluation.The root cause investigation is currently ongoing within capa 4344556.Based upon our investigation the complaint was confirmed.H3 other text : see h10.

• Brand Name: BD¿ ¿COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
• Type of Device: BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14017920
• MDR Text Key: 289442748
• Report Number: 9680577-2022-00046
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/28/2022
• Device Catalogue Number: 257306
• Device Lot Number: 2033567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1