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

Model Number 220837

Device Problem Contamination (1120)

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

Event Date 05/23/2023

Event Type  malfunction  

Event Description

It was reported that bd bbl¿ brain heart infusion media was contaminated prior to use.There was no report of patient impact.The following information was provided by the initial reporter: gram-negative rods detected microscopically on receipt of goods.

Manufacturer Narrative

E1.Initial reporter phone number: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd bbl¿ brain heart infusion media was contaminated prior to use.There was no report of patient impact.The following information was provided by the initial reporter: gram-negative rods detected microscopically on receipt of goods.

Manufacturer Narrative

H.6.Investigation summary: material 221788 and material 220837 are 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.Batch 3011172 the batch history record review for batch 3011172 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation and filling 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.The release testing that is performed on this product does include review of its color and clarity.Samples submitted are examined to ensure that they conform to typical levels.The appearance of this batch was satisfactory per internal procedures.Direct staining techniques are not part of qc release testing for this product.Additionally, 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 3011172 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples.For investigation, two retention tubes went into incubation.One tube was incubated in the 20-25 degrees celsius incubator, and the other tube was placed in the 33¿37-degree celsius incubator.At the seventh day of incubation there were no signs of turbidity or microbial growth.Batch 2279210 the batch history record review for batch 2279210 was satisfactory per internal procedures.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 was 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 one other complaint has been taken on this batch.Retention samples from batch 2279210 (10 tubes) were available for inspection.No media defects were observed in 10/10 retention samples.All retentions tubes had the expected appearance for this product of clear to trace hazy, light to medium dark yellow tan as described in the certificate of analysis.For investigation, two retention tubes went into incubation.One retention tube was placed into the 20¿25-degree celsius incubator and one retention tube was placed in the 33¿37-degree celsius incubator.At the seventh day of incubation there were no signs of growth or turbidity or change in media color and clarity.After incubation the broth appearance remained clear to trace hazy, light to medium dark yellow as described in the certificate of analysis.One photo was received to assist with the investigation: ¿ the photo shows a gram stain of one-gram negative rod.No product information is presented in the photo received.Without product verification a photo alone cannot confirm a complaint.A photo must provide the product, product defect, and important product information such as batch/lot number must be clear and visible.No returns were received to assist with the investigation.This complaint cannot be confirmed for batch 2279210 or 3011172.See h.10.

• Brand Name: BD BBL¿ BRAIN HEART INFUSION
• Type of Device: 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 ; 8448235433
• MDR Report Key: 17148322
• MDR Text Key: 317758231
• Report Number: 1119779-2023-00673
• Device Sequence Number: 1
• Product Code: JSC
• UDI-Device Identifier: 30382902208373
• UDI-Public: 30382902208373
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/03/2024
• Device Model Number: 220837
• Device Catalogue Number: 220837
• Device Lot Number: 2279210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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