MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) SEE H.10; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number	221787
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin appearance is cloudy and when gram stain was performed gram negative bacilli.The following information was provided by the initial reporter: these thio´s are slightly more "cloudy" than usual and when they perform a gram stain on them, they turn out to be full of gram negative bacilli.They are going to do another sterility check theirself, but they hear from colleagues in other laboratories, with the same problem, that they remain negative.Nevertheless, this has a serious impact on their working method.They always make a gram staining of grown thio´s.
Additional Manufacturer Narrative
Investigation summary: material 221787 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.Customer did not provide a batch number, photos or returns for this complaint investigation.Trending was done on the appropriate databases for thio vitamin k hemin 8ml (material 221787), and no quality notification trends have been identified for this material for contamination tube in the last 12 months.The complaint history was reviewed for material 221787 and there are no trends for contamination in the last 12 months.Bd will continue to trend complaints for this issue.This complaint cannot be confirmed based on material trending.
Event or Problem Description
It was reported that bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin appearance is cloudy and when gram stain was performed gram negative bacilli.The following information was provided by the initial reporter: these thio´s are slightly more "cloudy" than usual and when they perform a gram stain on them, they turn out to be full of gram negative bacilli.They are going to do another sterility check theirself, but they hear from colleagues in other laboratories, with the same problem, that they remain negative.Nevertheless, this has a serious impact on their working method.They always make a gram staining of grown thio´s.

• Brand Name: SEE H.10
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16882201
• Report Number: 1119779-2023-00531
• Device Sequence Number: 20648453
• Product Code: JSG
• UDI-Device Identifier: 30382902217870
• UDI-Public: 30382902217870
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 06/02/2023

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
• Operator of Device: Other
• Device Model Number: 221787
• Device Catalogue Number: 221787
• Device Lot Number: 2251076
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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