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

Catalog Number 220837

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 08/18/2023

Event Type  malfunction  

Manufacturer Narrative

There were three lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 3005711.D4.Medical device expiration date: 07-07-2024.H4.Device manufacture date: 05-01-2023.D4.Medical device lot#: 3060897.D4.Medical device expiration date: 25-08-2024.H4.Device manufacture date: 01-03-2023.E.1.Initial reporter prefix: (b)(6).E.1.Initial reporter phone #: (b)(6).E.1.Initial reporter facility name: (b)(6).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 prior to using bd bbl¿ brain heart infusion, there was biological contamination of 100 tubes across three batch numbers.No patient impact reported.The following information was provided by the initial reporter: "microscopic control from a sterile boullion revealed gram-negative rods.".

Event Description

It was reported that prior to using bd bbl¿ brain heart infusion, there was biological contamination of 100 tubes across three batch numbers.No patient impact reported.The following information was provided by the initial reporter: "microscopic control from a sterile boullion revealed gram-negative rods.".

Manufacturer Narrative

H.6 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 batches 3060897, 3005711, 3062729 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 batches 306897, 3005711, and 3062737.Retention samples from each batch 306897, 3005711, and 3062737.(10 tubes per batch) were available for inspection.No media defects were observed in 10/10 retention samples for each batch.All retention 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 of each batch 306897, 3005711, and 3062737 went into incubation.For each batch in question 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.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.No complaint trends for this defect has been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for defects.Caution should be exercised in reporting direct microbiological stain or molecular testing directly using this medium due to the possible presence of non-viable organisms in the culture medium.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media or detectible by molecular testing.Product should not be used if medium shows evidence of contamination, discoloration, drying or other signs of deterioration.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17632740
• MDR Text Key: 322072108
• Report Number: 1119779-2023-00948
• 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: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 220837
• Device Lot Number: 3062737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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