MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 257306

Device Problem Microbial Contamination of Device (2303)

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

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that 240 bd columbia cna agar with 5% sheep blood had biological contamination.The following information was provided by the initial reporter, translated from german to english: contaminated plates.

Manufacturer Narrative

There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ columbia cna agar with 5% sheep blood catalog number 221353 with 510k number preamendment.Investigation summary: complaint history review: 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).Batch history record (bhr) review: the batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Sample analysis: pictures were provided showing the reported contamination.The retention samples were reviewed and the plates were found to be without deviation.Evaluation results: 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 (# (b)(4)) were created for further evaluation.The root cause investigation is currently ongoing within the mentioned capa # (b)(4).Investigation conclusion: based upon our investigation the complaint was confirmed.

• Brand Name: BD COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD
• Type of Device: CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
• 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: 14120645
• MDR Text Key: 298797193
• Report Number: 9680577-2022-00060
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: SEE H10
• 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
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2022
• 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
• Date Manufacturer Received: 03/22/2022
• 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