MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Catalog Number 252631

Device Problem Contamination (1120)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

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 the bd bbl¿ chromagar¿ orientation agar was contaminated.There was no report of adverse user or patient impact.The following information was provided by the initial reporter, translated from spanish: the material has a stain.(b)(6) 2022/pw - issue is contamination based on photo review - verified by qe.

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 controls in the processes 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 a single contaminated plate is acceptable within the specification criteria.It is worth mentioning that the product was for 5 days outside the bd shelter.

Event Description

It was reported that the bd bbl¿ chromagar¿ orientation agar was contaminated.There was no report of adverse user or patient impact.The following information was provided by the initial reporter, translated from spanish: "the material has a stain" "(b)(6) 2022/pw - issue is contamination based on photo review - verified by qe".

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR
• 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
• 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: 14518363
• MDR Text Key: 299459654
• Report Number: 9614033-2022-00043
• Device Sequence Number: 1
• Product Code: JSH
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/27/2022
• Device Catalogue Number: 252631
• Device Lot Number: 1308077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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