MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 221093

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 09/12/2023

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¿ trypticase¿ soy broth, there was contamination of an unspecified number of tubes.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting contaminated tubes.

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy broth, there was contamination of an unspecified number of tubes.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting contaminated tubes.

Manufacturer Narrative

H.6.Investigation summary: material 221093 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 3129898 was satisfactory per internal procedures.Formulation, filling, torquing, and autoclaving processes were within specifications.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 one other complaint has been taken on this batch for contamination.Retention samples from batch 3129898 (10 tubes) were available for inspection.No microbial growth or turbidity were observed in 10/10 retention tubes.Retention tubes were incubated for investigation at 20 to 25 degrees c (1 tube) and 33 to 37 degrees c (1 tube).At seven days incubation, no microbial growth was observed in 2/2 tubes.Four photos were received for investigation.Two photos each show two tubes of tsb held up with what appears to a faint swirl of haze toward the bottom of the tube.One photo shows the side of four cartons from batch 3129898 with the carton labels featured (carton numbers 446 and 442 visible) for batch verification.The last photo features a carton label from enriched thioglycollate broth, material 221788, batch 3187508 (carton number 0212) which is the subject of another complaint from community blood center (complaint number 9044971).No return samples were received for investigation.The haziness shown in the photo could be due to contamination.However, the haziness in the photo cannot be identified for further investigation.The clarity specification for this product is clear to trace hazy.Media that is outside of the appearance specification should not be used.It should be noted that non-viable organisms can contribute to a hazy appearance of the media.If non-viables are present and causing the media to appear out of specification for clarity, the media should not be used.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.This complaint can be confirmed by the photo for turbidity that may be contamination.Bd will continue to trend complaints for defects.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• Type of Device: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17921493
• MDR Text Key: 325585388
• Report Number: 1119779-2023-01097
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902210932
• UDI-Public: 30382902210932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

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
• Device Operator: Other
• Device Catalogue Number: 221093
• Device Lot Number: 3129898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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