MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 221291

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

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar, the media was contaminated which led to false results.No patient impact or known change of treatment.The following information was provided by the initial reporter: what result did obtain from the bd product? shewanella putrefaciens what result was the customer expecting to obtain (if different from the obtained result) urine culture.Expected is no growth.Was media contamination noticed upon receiving or at a later time? later".

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-01201 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore, this is not considered to be a reportable malfunction.

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy agar with 5% sheep blood (tsa ii) // macconkey ii agar, the media was contaminated which led to false results.No patient impact or known change of treatment.The following information was provided by the initial reporter: what result did obtain from the bd product? shewanella putrefaciens.What result was the customer expecting to obtain (if different from the obtained result) urine culture.Expected is no growth.Was media contamination noticed upon receiving or at a later time?- later".

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18066900
• MDR Text Key: 327306654
• Report Number: 1119779-2023-01201
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 00382902212911
• UDI-Public: (01)00382902212911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/18/2023
• Device Catalogue Number: 221291
• Device Lot Number: 3248664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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