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 06/15/2022

Event Type  malfunction  

Event Description

It was reported that plate mueller hinton ii agar 20 ea plates were contaminated prior to use.The following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, bacterial growth was found in the mueller hinton media before usage.

Manufacturer Narrative

In this mdr, bd ds headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.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 preamendment 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 plate mueller hinton ii agar 20 ea plates were contaminated prior to use.The following information was provided by the initial reporter: this is a report about contamination of the media.According to the customer's report, bacterial growth was found in the mueller hinton media before usage.

Manufacturer Narrative

H.6 investigation summary: 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, a dish stuck issue was noted, however it is unclear if this was related to the reported defect.No trend was identified.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.H3 other text : see h.10.

• 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: 14881977
• MDR Text Key: 302267268
• Report Number: 1119779-2022-00953
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/25/2022
• Device Catalogue Number: 251177
• Device Lot Number: 2088793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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