MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD DIFCO¿ AGAR, GRANULATED; SUPPLEMENT, CULTURE MEDIA

Catalog Number 214530

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/11/2022

Event Type  malfunction  

Event Description

It was reported by the customer that they found some contamination in the jars from lot 2038654 on bd difco¿ agar, granulated.There was three occurrences in this event with no patient impact.The following information was provided by the customer: reported contamination lot 2038654 and found some contamination in the jars and are returning a total of 4 to us that we would like credit for.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

After further review this mdr is not reportable.This is dcm and looking at the photos it is not biological contamination - but fm.This mdr can be cancelled.

Event Description

It was reported by the customer that they found some contamination in the jars from lot 2038654 on bd difco¿ agar, granulated.There was three occurrences in this event with no patient impact.The following information was provided by the customer: " reported contamination lot 2038654 and found some contamination in the jars and are returning a total of 4 to us that we would like credit for.Attached is a picture of the contamination.".

• Brand Name: BD DIFCO¿ AGAR, GRANULATED
• Type of Device: SUPPLEMENT, CULTURE MEDIA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15452467
• MDR Text Key: 300578601
• Report Number: 1119779-2022-01209
• Device Sequence Number: 1
• Product Code: JSK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 214530
• Device Lot Number: 2038654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1