MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE COLUMBIA CNA AG 5PRCT SB 90MM

Catalog Number 254072

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

The customer reported slow growth of staphylococcus aureus strains isolated from patient samples when using the plate columbia cna ag 5prct sb 90mm.The same strains have a good growth on columbia blood agar without cna and on another lot of columbia blood agar with cna.The event occurred on 10 occasions.There was no report of patient impact.

Event Description

The customer reported slow growth of staphylococcus aureus strains isolated from patient samples when using the plate columbia cna ag 5prct sb 90mm.The same strains have a good growth on columbia blood agar without cna and on another lot of columbia blood agar with cna.The event occurred on 10 occasions.There was no report of patient impact.

Manufacturer Narrative

H.6.Investigation: this statement is to summarize findings of a complaint against columbia cna agar with 5% sheep blood, catalog number 254072, lot number 0294956.Event description: it was reported that staph aureus would be discordant.Complaint history review: the complaints trends were reviewed.There were no similar complaints received during that period on this product lot.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 plates with growth.An analysis of growth promotion for the media was performed on retention samples for batch 0294956.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.During this test, all strains referenced in the ifu were tested.However, lactobacillus was not referenced in the ifu.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.A definite root cause could not be determined.We would suggest that any prepared plated media be set aside and not use 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).H3 other text : see h.10.

• Brand Name: PLATE COLUMBIA CNA AG 5PRCT SB 90MM
• Type of Device: NA
• 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: 11219638
• MDR Text Key: 256144476
• Report Number: 9680577-2021-00001
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 11/05/2021

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: 01/13/2021
• Device Catalogue Number: 254072
• Device Lot Number: 0294956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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