MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM), PLATE, 90 MM X 20 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON

Catalog Number 254058

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

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

Event Date 11/22/2021

Event Type  malfunction  

Event Description

It was reported while testing with bd¿ haemophilus test medium agar (htm), plate, 90 mm x 20, there was no growth on media. Confirmatory testing was performed using a different media, and colonies grew correctly. There was no report of patient impact. 100 cases were affected. The following information was provided by the initial reporter, translated from (b)(6): the cultures plates aren't working properly. There is no colony growth on the plates. An alternative test has been carried out on other media and the colonies are growing correctly.

Manufacturer Narrative

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¿ haemophilus test medium agar (htm agar), catalog number 221954, with 510k # k894216b. A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD¿ HAEMOPHILUS TEST MEDIUM AGAR (HTM), PLATE, 90 MM X 20
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
• Manufacturer (Section D): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer (Section G): BECTON DICKINSON GMBH; 8-12 tullastrasse; heidelberg 69126 ; GM 69126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13029121
• MDR Text Key: 290307650
• Report Number: 9680577-2021-00099
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: SEE H10
• 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: 04/11/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/08/2021
• Device Catalogue Number: 254058
• Device Lot Number: 1257478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial