MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 211043

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

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy agar turbidity is observed.The following information was provided by the initial reporter: the presence of turbidity is detected in the prepared and sterilized culture medium.Turbidity is present in all bottles prepared with the new commercial batch of culture medium.The culture medium is subjected to a sterility test, which it complies with.

Manufacturer Narrative

Initial reporter email: (b)(6).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 1119779-2023-01074 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 turbidity is observed.The following information was provided by the initial reporter: ¿ the presence of turbidity is detected in the prepared and sterilized culture medium.¿ turbidity is present in all bottles prepared with the new commercial batch of culture medium ¿ the culture medium is subjected to a sterility test, which it complies with.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17906276
• MDR Text Key: 325302899
• Report Number: 1119779-2023-01074
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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: 10/26/2023

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 Catalogue Number: 211043
• Device Lot Number: 3114319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2023
• 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