MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, IMPROVED II, PLATE, 90 MM X 20; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 257303

Device Problem Contamination (1120)

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

Event Date 02/28/2022

Event Type  malfunction  

Event Description

It was reported that bd¿ columbia cna agar with 5% sheep blood, improved ii, plate, 90 mm x 20 plates were contaminated prior to use.40 plates were affected.The following information was provided by the initial reporter: agar plates arrived contaminated.

Manufacturer Narrative

(b)(6).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 with 5% sheep blood catalog number 2221352 which is a class 1, preamendment device.Event description: it was reported that 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 performed 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: picture sample was 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, a mrb (mrb (b)(4)) and cid ((b)(4)) were created for further evaluation.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.

• Brand Name: BD¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD, IMPROVED II, PLATE, 90 MM X 20
• 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: 13878156
• MDR Text Key: 296810079
• Report Number: 9680577-2022-00040
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• 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: 02/28/2022
• 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