Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 CHROMAGAR ORIENTATION 90MM EU 20EA; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
  • 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 CHROMAGAR ORIENTATION 90MM EU 20EA; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL Back to Search Results
Catalog Number 257481
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Event Description
It was reported that while using 4 plate chromagar orientation 90mm eu 20ea 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: "agar plates are contaminated with large blue colonies, making them unusable.There are 3 to 4 contaminated agars per bag of 10 agars.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default.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¿ chromagar¿ orientation agar (100 shelf pack) catalog number 215081 which is a class 1, 510(k) exempt device.
 
Event Description
It was reported that while using 4 plate chromagar orientation 90mm eu 20ea 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: "agar plates are contaminated with large blue colonies, making them unusable.There are 3 to 4 contaminated agars per bag of 10 agars.".
 
Manufacturer Narrative
H6: investigation summary: it was reported that several plates showed contamination was detected.Complaint history was reviewed and one similar complaint was recorded for the respective batch.However, since this product is filled aseptically with an aql for sterility of 1.5 rare contamination events are to be expected.Therefore, a trend could not be identified.The bhr was reviewed.No deviation from the validated processes and parameters were registered.The retain samples were reviewed and no deviation could be detected.Picture samples were not provided.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9%.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high quality standard, we only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Based on the evaluation and as no pictures were provided, the complaint was not confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PLATE CHROMAGAR ORIENTATION 90MM EU 20EA
Type of Device
CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
Manufacturer (Section D)
BECTON DICKINSON GMBH
8-12 tullastrasse
heidelberg 69126
GM  69126
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12836777
MDR Text Key286991580
Report Number9680577-2021-00081
Device Sequence Number1
Product Code JSH
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/05/2021
Device Catalogue Number257481
Device Lot Number1223071
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-