MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE TSA 5% SB//CHOCOLATE AGAR 100 EA; CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA

Catalog Number 251303

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

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.(b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the plate tsa 5% sb//chocolate agar 100 ea has been found experiencing 500 occurrences of insufficient growth.The following has been provided by the initial reporter: this is a report about insufficient growth.For use with a kiestra, the customer switched from mod sb (t)//choco to tsa 5% sb//chocolate.The customer reports that gonococci do not grow in the chocolate agar side, although they grow normally in blood agar side.The cause is undetermined since there were changes not only in plates used, but also application and cultivation of bacteria have changed to the kiestra.

Event Description

It has been reported that the plate tsa 5% sb//chocolate agar 100 ea has been found experiencing 500 occurrences of insufficient growth.The following has been provided by the initial reporter: this is a report about insufficient growth.For use with a kiestra, the customer switched from mod sb (t)//choco to tsa 5% sb//chocolate.The customer reports that gonococci do not grow in the chocolate agar side, although they grow normally in blood agar side.The cause is undetermined since there were changes not only in plates used, but also application and cultivation of bacteria have changed to the kiestra.

Manufacturer Narrative

H6: investigation summary since no photo or sample were returned we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed.H3 other text : see h10.

• Brand Name: PLATE TSA 5% SB//CHOCOLATE AGAR 100 EA
• Type of Device: CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14575957
• MDR Text Key: 301563297
• Report Number: 1119779-2022-00798
• Device Sequence Number: 1
• Product Code: JTY
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: 251303
• Device Lot Number: 2046018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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