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

Catalog Number 221788

Device Problem Contamination (1120)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bbl¿ brain heart infusion broth contamination was found.No patient impact occurred.The following information was provided by the initial reporter: presence of "flakes" and cloudiness inside the tubes.When did the incident occur? during use we inoculated 5 broths on pvx agar plates by flooding on the afternoon of thursday 3 august and there was a growth.

Manufacturer Narrative

H.6.Investigation summary: material 221788 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 2279225 was satisfactory per internal procedures.Formulation, filling, torquing, 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.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.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 2279225 (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 light to medium light yellow, trace hazy to clear.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.There was no change in the color and clarity in of the media.The media remained medium yellow clear to trace hazy as described in the certificate of analysis.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for contamination/appearance defects.The color and clarity of the media on batch 2279225 is light to medium light yellow, trace hazy to clear which is described in the certificate of analysis.As stated in the ifu for material 221788 (available on bd.Com/e-labeling), this media should be reduced by boiling prior to use.H3 other text : see h.10.

Event Description

It was reported that while using bd bbl¿ brain heart infusion broth contamination was found.No patient impact occurred.The following information was provided by the initial reporter: presence of "flakes" and cloudiness inside the tubes when did the incident occur? during use we inoculated 5 broths on pvx agar plates by flooding on the afternoon of thursday 3 august and there was a growth.

• Brand Name: BD BBL¿ BRAIN HEART INFUSION BROTH
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17574023
• MDR Text Key: 321659426
• Report Number: 1119779-2023-00904
• Device Sequence Number: 1
• Product Code: JSC
• UDI-Device Identifier: 30382902217887
• UDI-Public: 30382902217887
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 221788
• Device Lot Number: 2279225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2023
• 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