MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO PLATE MACCONKEY AGAR 100MM 10EA; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number 211662

Device Problem Contamination (1120)

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

Event Date 04/07/2022

Event Type  malfunction  

Event Description

It was reported that prior to use with the plate macconkey agar 100mm 10ea, plates were contaminated.The following information was provided by the initial reporter: client sends the following complaint about the mac conkey agar plate, lot: 1288823, ca: (b)(6) 2022; due to the presence of contamination in them.

Manufacturer Narrative

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¿ macconkey ii agar catalog number 221172 which is a class 1, exempt device.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 prior to use with the plate macconkey agar 100mm 10ea, plates were contaminated.The following information was provided by the initial reporter: "client sends the following complaint about the mac conkey agar plate, lot: 1288823, ca: 05/12/22; due to the presence of contamination in them.".

Manufacturer Narrative

H.6 investigation summary: the notified batch file was reviewed, verifying that all the processes were followed effectively during the manufacture of the product, likewise the batch was analyzed by the quality control department and the results were satisfactory for the release of the batch.It was not possible to carry out the revision of the retention samples because they had already fulfilled their life time, so they were purged.It is concluded that the event reported by the client is classified as confirmed based on the photographic evidence provided by the client, however, a root cause attributable to a failure in any of the process controls during the production or storage process was not identified.While the product was kept under the protection of bd.The product accepts an aql of 2.5, so two contaminated plates is acceptable within the specification criteria.It is worth mentioning that the product was for 154 days outside the bd shelter.

• Brand Name: PLATE MACCONKEY AGAR 100MM 10EA
• Type of Device: CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14289537
• MDR Text Key: 291753037
• Report Number: 9614033-2022-00035
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: 211662
• Device Lot Number: 1288823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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