MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ BRAIN HEART INFUSION; CULTURE MEDIA, GENERAL NUTRIENT BROTH

Model Number	220837
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	01/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ brain heart infusion upon receipt it was visually cloudy swirling in broth.The following information was provided by the initial reporter: customer state contamination= slightly cloudy swirling in broth.Usually indicates bacterial growth = plated to blood agar = no growth.
Event or Problem Description
It was reported that bd bbl¿ brain heart infusion upon receipt it was visually cloudy swirling in broth.The following information was provided by the initial reporter: customer state contamination= slightly cloudy swirling in broth.Usually indicates bacterial growth = plated to blood agar = no growth.
Additional Manufacturer Narrative
H6 investigation summary: material 220837 is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued, and then labeled by machine per standard operating 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.The batch history record review for batch 2124342 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr is reviewed to confirm the following: --the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.--all autoclave parameters conformed to the validated cycle parameters for this product.--the minimum f0 for this product was met.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 2124342 (10 tubes) were available for inspection.The retention samples showed no signs of contamination/ turbid or hazy media appearance in 10/10 retention tubes from visual inspection.All 10/10 retention tubes and a clear to trace hazy light yellow tan appearance as described in the certificate of analysis.For investigation, two uninoculated retention tubes were incubated.One tube was placed in the 33-to-37-degree celsius incubator and one tube was placed in the 20-to-25-degree celsius incubator.No microbial growth or turbidity of the media was seen in 2/2 incubated retention tubes at seven days incubation.One photo was received to assist with the investigation: ¿ the photo shows the label of a partial bd carton from batch 2124342 carton number 154.Returns were received to assist with the investigation.A small tube shipping carton was received with six tubes from batch 2124342.There was no evidence of contamination or turbid media in 6/6 returned tubes.All six returned tubes had the light-yellow tan clear to trace hazy appearance as described in the certificate of analysis.For further investigation of the returned samples received, all 6/6 returned tubes were incubated.Three tubes went into 20-25 degree celsius incubation, and three tubes went into 33-37-degree celsius incubation.At the end of a seven-day incubation period no microbial growth or cloudy media was observed in 6/6 incubated returned tubes.This complaint cannot be confirmed based on the evidence provided by the returned samples/photo.

• Brand Name: BD BBL¿ BRAIN HEART INFUSION
• Common Device Name: CULTURE MEDIA, GENERAL NUTRIENT BROTH
• 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: 16277884
• Report Number: 1119779-2023-00092
• Device Sequence Number: 6748339
• Product Code: JSC
• UDI-Device Identifier: 30382902208373
• UDI-Public: 30382902208373
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2023

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 Expiration Date: 11/02/2023
• Device Model Number: 220837
• Device Catalogue Number: 220837
• Device Lot Number: 2124342
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• 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