MAUDE Adverse Event Report: BECTON DICKINSON GMBH BIPLATE MACCON/COL CNA IMPR 5% SB120; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 257584

Device Problem Contamination (1120)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number: (b)(6).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¿ columbia cna agar w/5% sheep blood // macconkey ii agar catalog number 221600 which is a class 1, 510(k) exempt device.

Event Description

It was reported that while using biplate maccon/col cna impr 5% sb120 contamination 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: "contaminated plates.".

Manufacturer Narrative

Investigation summary this statement is to summarize findings on the recent complaint 3171507 against bd¿ macconkey ii agar / columbia cna agar improved ii with 5% sheep blood (biplate), catalog number 257584, lot number 1104466.Event description: it was reported that contamination was detected on some plates.Complaint history review: the complaints trends were reviewed.There were no similar complaints received on this batch number.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: the retain samples were reviewed and no deviation could be detected.Pictures were provided showing the reported contamination.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.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed (b)(6).For our continuous monitoring, we derive a contamination ratio for below this specified value.According to our high quality standard, 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.Investigation conclusion: based on the evaluation of the provided report and picture sample, the complaint was 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 you 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 while using biplate maccon/col cna impr 5% sb120 contamination 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: "contaminated plates.".

• Brand Name: BIPLATE MACCON/COL CNA IMPR 5% SB120
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12253435
• MDR Text Key: 264346119
• Report Number: 9680577-2021-00037
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2021

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: 07/01/2021
• Device Catalogue Number: 257584
• Device Lot Number: 1104466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 12/20/2021
• Supplement Dates FDA Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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