MAUDE Adverse Event Report: BECTON DICKINSON PLATE MUELLER HINTON II AGAR 20 EA; CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

Catalog Number 251177

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

Oem manufacture: (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 preamendment device.Investigation summary: the complaint was confirmed as the reported defect on a returned sample.The issue was contamination.No issue in dhr.No issue in retention sample.Root cause was undetermined.No trend.We will continue to monitor the trend this issue.

Event Description

It was reported that while using plate mueller hinton ii agar 20 ea contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "this is a report about contamination of the media.".

• Brand Name: PLATE MUELLER HINTON II AGAR 20 EA
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12193929
• MDR Text Key: 266732246
• Report Number: 2243072-2021-01917
• Device Sequence Number: 1
• Product Code: JTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/23/2021
• Device Catalogue Number: 251177
• Device Lot Number: 1095123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/05/2021
• 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