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

Catalog Number 257303

Device Problem Contamination (1120)

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

Event Date 02/09/2022

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Address information was not able to be obtained, based on facility name.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that before using bd bbl¿ columbia cna agar with 5% sheep blood the customer observed biological contamination of the media.This event occurred 1 time.There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: we have a lot of contaminated agar lately on the anc reference ref 257303 and lot number 2004161microbial conta probably to micrococcus", in a tower of 10 agars 2 were contaminated.

Manufacturer Narrative

H.6.Investigation: this statement is to summarize findings on the recent complaint against columbia cna 5% sb improved, catalog number 257303, lot number 2004161.Event description: it was reported that several plates would have show contamination.Complaint history review: the complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was perormed and the results were documented within a cid (corrective and preventive action initiation determination).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 not provided.The retention samples were reviewed and one plate with contamination was detected.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, further evaluation will be conducted via the cid.As a root cause it could be identified that the blood pool which was used during a timely isolated production frame was contaminated.The contaminant which was also identified on one plate in the retain samples, is easy detectable as it grows before incubation.Investigation conclusion: based upon our investigation the complaint was confirmed.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).

Event Description

It was reported that before using bd bbl¿ columbia cna agar with 5% sheep blood the customer observed biological contamination of the media.This event occurred 1 time.There is no indication that false results were reported to health care practitioners.There is no indication of patient impact.The following information was provided by the initial reporter: ".We have a lot of contaminated agar lately on the anc reference ref 257303 and lot number 2004161microbial conta probably to micrococcus", ".In a tower of 10 agars 2 were contaminated.".

• Brand Name: BD BBL¿ 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: 13664629
• MDR Text Key: 291329034
• Report Number: 9680577-2022-00032
• Device Sequence Number: 1
• Product Code: JSJ
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 257303
• Device Lot Number: 2004161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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