MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE MUELLER HINTON II AGAR 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH

Catalog Number 251177

Device Problem Contamination (1120)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

In this mdr, (b)(4).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¿ mueller hinton ii agar, catalog number 211438, which is a pre-amendment device.Initial reporter facility name: (b)(6) hospital.

Event Description

It was reported that prior to use, plate mueller hinton ii agar 20 ea media was contaminated.The following information was provided by the initial reporter: according to the customer's report, bacterial growth was found in the media.

Event Description

It was reported that prior to use, plate mueller hinton ii agar 20 ea media was contaminated.The following information was provided by the initial reporter: according to the customer's report, bacterial growth was found in the media.

Manufacturer Narrative

H.6 investigation summary: material #: 251177.Lot/batch #: 2094818.Bd had not received samples or photos for investigation.Therefore, retention samples from bd inventory were evaluated and no issues were observed relating to contamination.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for contamination.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: PLATE MUELLER HINTON II AGAR 20 EA
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH
• 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: 15079591
• MDR Text Key: 303812571
• Report Number: 1119779-2022-01015
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 251177
• Device Lot Number: 2094818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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