MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	221787
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.E.1.Initial reporter facility name : (b)(6) hospital.B3: date of event is unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported when using the bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin customer has seen particles in the liquid medium.There was no report of impact to patient or user.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 1119779-2023-01361 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 or Problem Description
It was reported when using the bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin customer has seen particles in the liquid medium.There was no report of impact to patient or user.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• Common Device Name: 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: 18314721
• Report Number: 1119779-2023-01361
• Device Sequence Number: 15114157
• Product Code: JSG
• UDI-Device Identifier: 30382902217870
• UDI-Public: (01)30382902217870
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K803023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Operator of Device: Other
• Device Expiration Date: 01/08/2024
• Device Catalogue Number: 221787
• Device Lot Number: 3005714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown