MAUDE Adverse Event Report: BECTON DICKINSON GMBH BD PLATE CHOCO GC AGAR W/ISOVITALEX 90MM CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

Catalog Number 254089

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

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

It was reported that while using 4 bd plate choco gc agar w/isovitalex 90mm by the laboratory personnel. A cepheid test was used to confirm the results as false positives. 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: "customer found 4 contaminated bd chocolate agar plates with visible bacterial growth prior to use of those plates. ".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. 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¿ gc ii agar with isovitalex¿ enrichment catalog number 221240 which has 510k k945569.

• Brand Name: BD PLATE CHOCO GC AGAR W/ISOVITALEX 90MM
• Type of Device: CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
• 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: 12980821
• MDR Text Key: 289199292
• Report Number: 9680577-2021-00094
• Device Sequence Number: 1
• Product Code: JSO
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K945569
• 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: 12/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/20/2021
• Device Catalogue Number: 254089
• Device Lot Number: 1264059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial