MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE COLUMBIA CNA AG 5PRCT SB 90MM; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 254072

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 plate columbia cna ag 5prct sb 90mm catalog number 221352 which is a class 1, 510(k) exempt device.

Event Description

It was reported that while using plate columbia cna ag 5prct sb 90mm atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "i had again some issues with agar anc ref 254072 lot 1019421 as you can see from the photos, for the same patient with the same incubation time, i have beautiful colonies of staph aureus on cos, while almost nothing has grown on anc, and in a polymorphic way.The problem is random, i have other ncas on which colonies grow well.Description detailed received on the 23rd of march : with some boxes of this batch 1019421, staphylococcus aureus cultures are difficult while the same isolated blood columbia agar sample gives a nice culture.The samples tested are multiple (superficial sampling, deep sampling, dialysis fluids.).The boxes are incubated in a kiestra reada 2 chain (35°c, 18h, 5% co2).".

Event Description

It was reported that while using plate columbia cna ag 5prct sb 90mm atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "i had again some issues with agar anc ref 254072 lot 1019421 as you can see from the photos, for the same patient with the same incubation time, i have beautiful colonies of staph aureus on cos, while almost nothing has grown on anc, and in a polymorphic way.The problem is random, i have other ncas on which colonies grow well.Description detailed received on the 23rd of march : with some boxes of this batch 1019421, staphylococcus aureus cultures are difficult while the same isolated blood columbia agar sample gives a nice culture.The samples tested are multiple (superficial sampling, deep sampling, dialysis fluids.).The boxes are incubated in a kiestra reada 2 chain (35°c, 18h, 5% co2).".

Manufacturer Narrative

H.6.Investigation: this statement is to summarize findings on the recent complaint (b)(4) against columbia cna agar with 5% sheep blood, catalog number 254072, lot number 1019421.Complaint history review: the complaints trends were reviewed.There were no similar confirmed complaints received on this product.Therefore, a trend could not be identified.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 a plate with less growth.An analysis of growth promotion for the media was performed on retention samples for batch 1019421.The performance tests on retention samples of the above mentioned batch resulted in excellent growth of the following strains: - str.Pyogenes atcc 19615.- str.Pneumoniae atcc 6305.- staph.Aureus atcc 25923.- e.Faecalis atcc 29212.- e.Coli atcc 25922.After an incubation time of 1 day at 36°c ± 1°c in co2 atmosphere.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our production process.No deviation could be found during the qc performance test.Investigation conclusion: based on the evaluation of the report and based on the qc test results, the complaint was not confirmed.A corrective and preventive action will not be implemented as a trend could not be identified.We would suggest to set aside, and not use, any prepared plated media that does not meet the appearance specification as it is described on the bd certificate of analysis.This is consistent with industry recommendations for inspection of culture media prior to use (e.G.¿good practices for pharmaceutical microbiology laboratories¿, who technical report series, no.961, 2011, annex 2; chapter <1117> ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).

• Brand Name: PLATE COLUMBIA CNA AG 5PRCT SB 90MM
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11672190
• MDR Text Key: 280540871
• Report Number: 9680577-2021-00015
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 11/22/2021

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: 04/14/2021
• Device Catalogue Number: 254072
• Device Lot Number: 1019421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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