MAUDE Adverse Event Report: BECTON DICKINSON GMBH PLATE BBL CHROMAGAR MRSA II 90MM 120 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

Catalog Number 257435

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

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.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¿ chromagar® mrsa ii 100mm (20 each) catalog number 215228 which has 510k number k092767.

Event Description

It was reported that while using 5 plate bbl chromagar mrsa ii 90mm 120 ea atypical growth was observed by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: " after a long hot transport (more than 4 days from belgium) on the mrsa plate grow mrsa and mssa.We are not sure if it is an plate problem or an transport problem.".

Manufacturer Narrative

H.6.Investigation: this statement is to summarize findings on the recent complaint (b)(4) for bbl¿ chromagar¿ mrsa ii, catalog number 257435, lot number 1126698.Event description: it was reported that after a long hot transport mrsa and mssa strains did grow on the plates.Complaint history review: the complaints trends were reviewed for a period covering 12 months.There were no confirmed complaints received during that period 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 plates with growth.An analysis of growth promotion for the media was performed on retention samples for batch 1126698.The performance tests on retention samples of the above mentioned batch resulted in excellent growth of the following strains: staph.Aureus mrsa atcc 33592, incubation time 20-22 hours at 35-37°c in aerob atmosphere.Staph.Aureus mrsa atcc 43300 incubation time 20-22 hours at 35-37°c in aerob atmosphere.The following strains resulted in complete inhibition, as expected: staph.Aureus mssa atcc 25923, incubation time 48 hours at 35-37°c in aerob atmosphere.Staph.Aureus mssa atcc 29213, incubation time 48 hours at 35-37°c in aerob atmosphere.Staph.Aureus mssa atcc 43387, incubation time 48 hours at 35-37°c in aerob atmosphere.No deviation could be detected on the retention samples regarding the performance of the media.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 that to 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).

Event Description

It was reported that while using 5 plate bbl chromagar mrsa ii 90mm 120 ea atypical growth was observed by the laboratory personnel.The customer stated there was no patient impact.The following information was provided by the initial reporter: " after a long hot transport (more than 4 days from belgium) on the mrsa plate grow mrsa and mssa.We are not sure if it is an plate problem or an transport problem.".

• Brand Name: PLATE BBL CHROMAGAR MRSA II 90MM 120 EA
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12334019
• MDR Text Key: 267065466
• Report Number: 9680577-2021-00045
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092767
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/28/2021
• Device Catalogue Number: 257435
• Device Lot Number: 1126698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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