MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO PLATE BBL CHROMAGAR ORIENTAT 100MM 10EA; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Catalog Number 252631

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that while using 10 plates bbl chromagar orientat 100mm 10ea a mix of products in the pack was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: "bag with plates of two different codes.User does not indicate further information.".

Manufacturer Narrative

The following field was updated due to additional information: d.4.Medical device lot#: 1182816.H.6.Investigation: the notified batch file was reviewed, verifying that all processes were effectively followed during the manufacture of the product, observing compliance with the controls in process, which includes performing the line clearance for each batch; as well as obtaining satisfactory results in final inspection.It is observed that at least seven batches were manufactured between and the closest batch of chromagar orientator and the batch of chromagar candida reported with mixing.According to the information provided by the client and the revised production records, it is concluded that it is not possible that the product mix reported by the client has been generated in the plant, therefore it is not possible to determine a root cause of the reported event.The retention samples were reviewed without finding a product mixture, the photographs sent by the customer were reviewed without detecting a product mixture.H3 other text : see h.10.

Event Description

It was reported that while using 10 plates bbl chromagar orientat 100mm 10ea a mix of products in the pack was observed by the laboratory personnel.There was no report of impact.The following information was provided by the initial reporter: " bag with plates of two different codes.User does not indicate further information.".

• Brand Name: PLATE BBL CHROMAGAR ORIENTAT 100MM 10EA
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 12470905
• MDR Text Key: 272489309
• Report Number: 9614033-2021-00105
• Device Sequence Number: 1
• Product Code: JSH
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 252631
• Device Lot Number: 1182816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1