MAUDE Adverse Event Report: BECTON DICKINSON GMBH BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTH; CULTURE MEDIA

Catalog Number 299107

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 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

It was reported while using bbl medium culture 100ml trypticase soy broth there was insufficient growth on media.When plated liquid media to tsa, obtained pure growth.There was no report of patient impact.5 cases were affected.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/11/2021.H.6.Investigation: this memo is to summarize findings on the recent complaint (b)(4) for bbl¿ trypticase¿ soy broth, batch number 0259640 and catalog number 299107.Event description: it was reported that aspergillus brasiliensis atcc 16404 and candida albicans atcc 10231 would not grow.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 showing bottles and a description of the strains used in them.Also, physical sample was provided for further evaluation.A contamination test was performed with the returned samples and no contamination could be detected.An analysis of growth promotion for the media was performed on retention samples.The performance tests on retention samples of the above mentioned batch resulted in excellent growth of the following strains: candida albicans atcc 10231.Aspergillus brasiliensis atcc 16404.After an incubation time of 5 days at 22,5°c ± 2,5°c in aerob 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.The strain did grow as expected.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 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).

Event Description

It was reported while using bbl medium culture 100ml trypticase soy broth there was insufficient growth on media.When plated liquid media to tsa, obtained pure growth.There was no report of patient impact.5 cases were affected.

• Brand Name: BBL MEDIUM CULTURE 100ML TRYPTICASE SOY BROTH
• Type of Device: CULTURE MEDIA
• 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: 11223174
• MDR Text Key: 229592934
• Report Number: 9680577-2021-00003
• Device Sequence Number: 1
• Product Code: JSE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,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

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: 299107
• Device Lot Number: 0259640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2020
• 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