• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON GMBH PLATE CHOCO GC AGAR W/ISOVITALEX 90MM CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON Back to Search Results
Catalog Number 254089
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1076973. Medical device expiration date: 2021-06-14. Device manufacture date: 2021-03-17. Medical device lot #: 1069887. Medical device expiration date: 2021-06-08. Device manufacture date: 2021-03-10. 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 number k945569.
 
Event Description
It was reported that while using 171 plate choco gc agar w/isovitalex 90mm a missing label was observed by the laboratory personnel. There was no report of patient impact. The following information was provided by the initial reporter: "the plates are completely without a label. Since the boxes are already gone, it is not possible to verify whether it is batch 1076973 or 1069887. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePLATE CHOCO GC AGAR W/ISOVITALEX 90MM
Type of DeviceCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON
Manufacturer (Section D)
BECTON DICKINSON GMBH
8-12 tullastrasse
heidelberg 69126
GM 69126
MDR Report Key11916819
MDR Text Key280751107
Report Number9680577-2021-00017
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
PMA/PMN Number
K945569
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number254089
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

-
-